20210520

Contents

1. Working directories
2. VPN
3. Getting Started | Qv2ray
4. ClinicalTrials.gov
1. 4.1. Glossary of Common Site Terms
2. 4.2. Downloading Content for Analysis - ClinicalTrials.gov
5. Web Log
1. 5.1. Search of: COVID-19 - List Results - ClinicalTrials.gov
2. 5.2. URL in mermaid
6. Download
7. HIV treatment
1. 7.1. Selected clinical trials

Working directories

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TZ='Asia/Shanghai' date -d '2021-05-20 18:22:06.658 GMT' +'%F %H:%M:%S.%N %Z' # 0222
TZ='Asia/Shanghai' date -d '2021-05-20 18:22:06.658 GMT' +'%F %H:%M:%S.%3N %Z' # 0222
date -d '2021-05-20 18:22:06.658 GMT' +'%F %H:%M:%S.%3N %Z' TZ='Asia/Shanghai' # 0222
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TZ=GMT date -d ${i} 'CST' +'%F %T %Z'
date +"%Z %z"
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cut -d"," -f2- 
cat 2.csv | cut -d"Z" -f2- > Data.csv

VPN

Getting Started | Qv2ray

# QV2Ray
#
sudo apt install gnupg ca-certificates curl
sudo apt update; sudo apt install qv2ray
#
flatpak install flathub com.github.Qv2ray
flatpak run com.github.Qv2ray # run

setsid chromium-browser https://merlinblog.xyz/wiki/freess.html  https://www.facebook.com/groups/139561307215714/  https://sites.google.com/site/ssrandv2rayandss/zui-xin-mian-fei-shou-feiv2ray-ding-yue-de-zhi  https://raw.githubusercontent.com/ssrsub/ssr/master/v2ray  https://qv2ray.net/lang/zh/getting-started/step3.html#%E5%88%86%E4%BA%AB%E9%93%BE%E6%8E%A5  https://appimage.github.io/Qv2ray/  https://qv2ray.net/getting-started/step2.html#download-v2ray-core-files  https://github.com/v2fly/v2ray-core/releases  https://www.v2fly.org/guide/start.html#%E5%AE%A2%E6%88%B7%E7%AB%AF  https://github.com/v2fly/v2ray-core/releases  https://tracker.debian.org/pkg/golang-v2ray-core  https://flathub.org/apps/details/com.github.Qv2ray  https://github.com/Qv2ray/qv2ray.github.io  chrome://downloads/

ClinicalTrials.gov

ClinicalTrials.gov Identifier

Primary outcome measure

In a clinical study’s protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Secondary outcome measure

In a clinical study’s protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
First submitted that met QC criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM’s QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.

Glossary of Common Site Terms

This glossary will help you understand words and phrases frequently used on ClinicalTrials.gov. Many of these words are also used by clinical researchers and others in the same or a similar manner. But the definitions below are provided to explain content on ClinicalTrials.gov only.

For help with medical terms, see the MedlinePlus® Medical Encyclopedia.

Study record managers should refer to the Protocol Registration Data Element Definitions, Expanded Access Data Element Definitions, and Results Data Element Definitions for help with the data items required to register a study and submit results using the ClinicalTrials.gov Protocol Registration and Results System.

Accepts healthy volunteers
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
Active comparator arm
An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.
Adverse event
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied.
Age or age group
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups:

The age groups are:

* Child (birth-17)
* Adult (18-64)
* Older Adult (65+)

All-cause mortality
A measure of all deaths, due to any cause, that occur during a clinical study.
Allocation
A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized.
Arm
A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment , or no intervention, according to the trial’s protocol .
Arm type
A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm , active comparator arm , placebo comparator arm , sham comparator arm , and no intervention arm .
Baseline characteristics
Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).
Canceled submission
Indicates that the study sponsor or investigator recalled a submission of study results before quality control (QC) review took place. If the submission was canceled on or after May 8, 2018, the date is shown. After submission of study results, a study record cannot be modified until QC review is completed, unless the submission is canceled.
Certain agreements
Information required by the Food and Drug Administration Amendments Act of 2007 . In general, this is a description of any agreement between the sponsor of a clinical study and the principal investigator (PI) that does not allow the PI to discuss the results of the study or publish the study results in a scientific or academic journal after the study is completed.
Certification
A sponsor or investigator may submit a certification to delay submission of results information if they are applying for FDA approval of a new drug or device, or new use of an already approved drug or device. A sponsor or investigator who submits a certification can delay results submission up to 2 years after the certification/extension first submitted date, unless certain events occur sooner. See Delay Results Type in the Results Data Element definitions for more information about this certification.
Certification/extension first posted
The date on which information about a certification to delay submission of results or an extension request was first available on ClinicalTrials.gov. ClinicalTrials.gov does not indicate whether the submission was a certification or extension request. There is typically a delay between the date the study sponsor or investigator submitted the certification or extension request and the first posted date .
Certification/extension first submitted
The date on which the study sponsor or investigator first submitted a certification or an extension request to delay submission of results. A sponsor or investigator who submits a certification can delay results submission up to 2 years after this date, unless certain events occur sooner. There is typically a delay between the date the certification or extension request was submitted and the date the information is first available on ClinicalTrials.gov ( certification/extension first posted ).
Certification/extension first submitted that met QC criteria
The date on which the study sponsor or investigator first submitted a certification or an extension request that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a certification or extension request one or more times before NLM’s QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria. Meeting QC criteria for an extension request does not mean that the National Institutes of Health (NIH) has determined that the request demonstrates good cause. The process for review and granting of extension requests by the NIH is being developed.
City and distance
In the search feature, the City field is used to find clinical studies with locations in a specific city. The Distance field is used to find studies with locations within the specified distance from a city in number of miles. For example, if you choose Illinois as the state , identifying “Chicago” as the city and “100 miles” as the distance will find all studies listing a location within 100 miles of Chicago.
Clinical study
A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional studies (also called clinical trials) and observational studies .
Clinical trial
Another name for an interventional study .
ClinicalTrials.gov identifier (NCT number)
The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is “NCT” followed by an 8-digit number (for example, NCT00000419).
Collaborator
An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Condition/disease
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Contact
The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
Country
In the search feature, the Country field is used to find clinical studies with locations in a specific country. For example, if you choose the United States, you can then narrow your search by selecting a state and identifying a city and distance .
Cross-over assignment
A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two-by-two cross-over assignment involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A. So during the trial, participants “cross over” to the other drug. All participants receive drug A and drug B at some point during the trial but in a different order, depending on the group to which they are assigned.
Data Monitoring Committee (DMC)
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial . The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.
Early Phase 1 (formerly listed as Phase 0)
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
Eligibility criteria
The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers , has age or age group requirements, or is limited by sex .
Enrollment
The number of participants in a clinical study. The “estimated” enrollment is the target number of participants that the researchers need for the study.
Exclusion criteria
A type of eligibility criteria . These are reasons that a person is not allowed to participate in a clinical study.
Expanded access
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA) . Also called compassionate use. There are different expanded access types .

For more information, see FDA Expanded Access: Information for Patients.

Expanded access status
- Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
- No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
- Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
- Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
Expanded access type
Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
- Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA . This category also includes access in an emergency situation.
- Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA . This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA .
- Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA . This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
Experimental arm
An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial.
Extension request
In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date ). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing masked trial). All requests must be reviewed and granted by the National Institutes of Health. This process for review and granting of extension requests is being developed. See Delay Results Type in the Results Data Element definitions for more information.
Factorial assignment
A type of intervention model describing a clinical trial in which groups of participants receive one of several combinations of interventions. For example, two-by-two factorial assignment involves four groups of participants. Each group receives one of the following pairs of interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo and drug B, or (4) a placebo and a placebo. So during the trial, all possible combinations of the two drugs (A and B) and the placebos are given to different groups of participants.
FDAAA 801 Violations
A FDAAA 801 Violation is shown on a study record when the U.S. Food and Drug Administration (FDA) has issued a Notice of Noncompliance to the responsible party of an applicable clinical trial. A Notice of Noncompliance indicates that the FDA has determined the responsible party was not in compliance with the registration or results reporting requirements for the clinical trial under the Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801).

The National Library of Medicine (NLM) is required by FDAAA 801 to add information to a study record about any FDAAA 801 Violation. This information is provided by the FDA. There are three categories of information that may be included:

* Violation: Shown when the FDA issues a Notice of Noncompliance and posts the Notice of Noncompliance on its designated webpage. There are three types of violations:
  * Failure to submit required clinical trial information
  * Submission of false or misleading clinical trial information
  * Failure to submit primary and secondary outcomes
* Correction: Shown when the FDA confirms that the responsible party has updated the study record to correct the violation and posts the correction notice on its designated webpage. Because of the time for FDA review and processing, there may be a delay between the date when the study record was updated and the addition of correction information to the FDAAA 801 Violation information.
* Penalty: Shown when the FDA imposes a penalty for the violation and posts the penalty notice on its designated webpage.

First posted
The date on which the study record was first available on ClinicalTrials.gov. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
First submitted
The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record’s availability on ClinicalTrials.gov (the first posted date).
First submitted that met QC criteria
The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM’s QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)
U.S. Public Law 110-85, which was enacted on September 27, 2007. Section 801 of FDAAA amends Section 402 of the U.S. Public Health Service Act to expand ClinicalTrials.gov and create a clinical study results database . For more information on FDAAA 801, see the History, Policies, and Laws page on this site.
Funder type
Describes the organization that provides funding or support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting. Organizations listed as sponsors and collaborators for a study are considered the funders of the study. ClinicalTrials.gov refers to four types of funders:
- U.S. National Institutes of Health
- Other U.S. Federal agencies (for example, Food and Drug Administration, Centers for Disease Control and Prevention, or U.S. Department of Veterans Affairs)
- Industry (for example: pharmaceutical and device companies)
- All others (including individuals, universities, and community-based organizations)
Gender-based eligibility
A type of eligibility criteria that indicates whether eligibility to participate in a clinical study is based a person’s self-representation of gender identity or gender (yes, no). Gender is distinct from sex .
Group/cohort
A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Human subjects protection review board
A group of people who review, approve, and monitor the clinical study’s protocol . Their role is to protect the rights and welfare of people participating in a study (referred to as human research subjects), such as reviewing the informed consent form . The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also called an institutional review board, or IRB, or an ethics committee.

For more information, see Participating in Studies on this site.

Inclusion criteria
A type of eligibility criteria . These are the reasons that a person is allowed to participate in a clinical study.
Informed consent
A process used by researchers to communicate to potential and enrolled participants the risks and potential benefits of participating in a clinical study.

For more information, see Participating in Studies on this site.

Informed consent form (ICF)
The document used in the informed consent or process.
Intervention model
The general design of the strategy for assigning interventions to participants in a clinical study. Types of intervention models include: single group assignment , parallel assignment , cross-over assignment , and factorial assignment .
Intervention/treatment
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Interventional study (clinical trial)
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study’s protocol . Participants may receive diagnostic, therapeutic, or other types of interventions.
Investigator
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator .
Last update posted
The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study’s sponsor or investigator (the last update submitted date) and the last update posted date.
Last update submitted
The most recent date on which the study sponsor or investigator submitted changes to a study record to ClinicalTrials.gov. There is typically a delay of a few days between the last update submitted date and when the date changes are posted on ClinicalTrials.gov (the last update posted date).
Last update submitted that met QC criteria
The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
Last verified
The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study’s recruitment status is shown as unknown .
Listed location countries
Countries in which research facilities for a study are located. A country is listed only once, even if there is more than one facility in the country. The list includes all countries as of the last update submitted date; any country for which all facilities were removed from the study record are listed under removed location countries .
Location terms
In the search feature, the Location terms field is used to narrow a search by location-related terms other than Country, State, and City or distance. For example, you may enter a specific facility name (such as National Institutes of Health Clinical Center) or a part of a facility name (such as Veteran for studies listing Veterans Hospital or Veteran Affairs in the facility name). Note: Not all study records include this level of detail about locations.
Masking
A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. Types of masking include: open label, single blind masking, and double-blind masking.
NCT number
A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is “NCT” followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier .
No intervention arm
An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial.
Observational study
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment .

A patient registry is a type of observational study.

Observational study model
The general design of the strategy for identifying and following up with participants during an observational study . Types of observational study models include cohort, case-control, case-only, case-cross-over, ecologic or community studies, family-based, and other.
Other adverse event
An adverse event that is not a serious adverse event , meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect; it also does not put the participant in danger and does not require medical or surgical intervention to prevent one of the results listed above.
Other study IDs
Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study’s sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
Other terms
In the search feature, the Other terms field is used to narrow a search. For example, you may enter the name of a drug or the NCT number of a clinical study to limit the search to study records that contain these words.
Outcome measure
For clinical trials , a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies , a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure .
Parallel assignment
A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A “in parallel” to participants in the other group, who receive drug B.
Participant flow
A summary of the progress of participants through each stage of a clinical study, by study arm or group/cohort . This includes the number of participants who started, completed, and dropped out of the study.
Patient registry
A type of observational study that collects information about patients’ medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA) . The phase is based on the study’s objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0) , Phase 1 , Phase 2 , Phase 3 , and Phase 4 . Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase 1
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug’s most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.
Phase 2
A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug’s effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo ) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Phase 3
A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Phase 4
A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug’s safety, efficacy, or optimal use.
Phase Not Applicable
Describes trials without FDA-defined phases , including trials of devices or behavioral interventions.
Placebo
An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
Placebo comparator arm
An arm type in which a group of participants receives a placebo during a clinical trial.
Primary completion date
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure . Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The “estimated” primary completion date is the date that the researchers think will be the primary completion date for the study.
Primary outcome measure
In a clinical study’s protocol , the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment . Most clinical studies have one primary outcome measure, but some have more than one.
Primary purpose
The main reason for the clinical trial . The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.
Principal investigator (PI)
The person who is responsible for the scientific and technical direction of the entire clinical study.
Protocol
The written description of a clinical study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information.
Quality control (QC) review
National Library of Medicine (NLM) staff perform a limited review of submitted study records for apparent errors, deficiencies, or inconsistencies. NLM staff identify potential major and advisory issues and provide comments directly to the study sponsor or investigator. Major issues identified in QC review must be addressed or corrected (see First submitted that met QC criteria and Results first submitted that met QC criteria ). Advisory issues are suggestions to help improve the clarity of the record. NLM staff do not verify the scientific validity or relevance of the submitted information. The study sponsor or investigator is responsible for ensuring that the studies follow all applicable laws and regulations.
Randomized allocation
A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance.
Recruitment status
- Not yet recruiting: The study has not started recruiting participants.
- Recruiting: The study is currently recruiting participants.
- Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
- Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
- Suspended: The study has stopped early but may start again.
- Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
- Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant’s last visit has occurred).
- Withdrawn: The study stopped early, before enrolling its first participant.
- Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.
Registration
The process of submitting and updating summary information about a clinical study and its protocol , from its beginning to end, to a structured, public Web-based study registry that is accessible to the public, such as ClinicalTrials.gov.
Removed location countries
Countries that appeared under listed location countries but were removed from the study record by the sponsor or investigator.
Reporting group
A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different from a study arm or group.
Responsible party
The person responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information. Usually the study sponsor or investigator.
Results database
A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results information for completed or terminated clinical studies. A study with results available on ClinicalTrials.gov is described as having the results “posted.”

Note: The ClinicalTrials.gov results database became available in September 2008. Older studies are unlikely to have results available in the database.

Results delayed
Indicates that the sponsor or investigator submitted a certification or extension request .
Results first posted
The date on which summary results information was first available on ClinicalTrials.gov. There is typically a delay between the date the study sponsor or investigator first submits summary results information (the results first submitted date) and the results first posted date.
Results first submitted
The date on which the study sponsor or investigator first submits a study record with summary results information. There is typically a delay between the results first submitted date and when summary results information becomes available on ClinicalTrials.gov (the results first posted date).
Results first submitted that met QC criteria
The date on which the study sponsor or investigator first submits a study record with summary results information that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit results information one or more times before NLM’s QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
Results returned after quality control review
The date on which the National Library of Medicine provided quality control (QC) review comments to the study sponsor or investigator. The sponsor or investigator must address major issues identified in the review comments. If there is a date listed for results returned after quality control review, but there is not a subsequent date listed for results submitted to ClinicalTrials.gov , this means that the submission is pending changes by the sponsor or investigator.
Results submitted to ClinicalTrials.gov
Indicates that the study sponsor or investigator has submitted summary results information for a clinical study to ClinicalTrials.gov but the quality control (QC) review process has not concluded.

The results submitted date indicates when the study sponsor or investigator first submitted summary results information or submitted changes to summary results information. Submissions with changes are typically in response to QC review comments from the National Library of Medicine (NLM). If there is a date listed for results submitted to ClinicalTrials.gov, but there is not a subsequent date listed for results returned after quality control review , this means that the submission is pending review by NLM.

Secondary outcome measure
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HIV treatment

Search of: treatment | hiv - List Results - ClinicalTrials.gov

cat HIV_ClinicalTrials.tsv | awk -F'\t' '{print $5}' | sort | uniq
#
cat HIV_ClinicalTrials.tsv | awk -F'\t' '{print $5}' | grep -n Completed | wc -l # output 4518
#
cat HIV_ClinicalTrials.tsv | ag -i 'Traditional Chinese Medicine'
# NCT00974454
# NCT00974519

Selected clinical trials

Search of: treatment | Completed Studies | hiv - List Results - ClinicalTrials.gov

Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults - Full Text View - ClinicalTrials.gov

Effectiveness of Antiretroviral Therapy During Acute HIV Infection - Full Text View - ClinicalTrials.gov

Effectiveness of Antiretroviral Therapy During Acute HIV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00705926

Recruitment Status : Completed

First Posted : June 27, 2008

Last Update Posted : August 31, 2017

Sponsor:

Massachusetts General Hospital

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party):

Eric Rosenberg, MD, Massachusetts General Hospital

Study Description

Go to sections

Brief Summary:

This study will determine whether HIV treatment that is initiated during the acute phase of HIV infection, followed by discontinuation of treatment, is effective in reducing the amount of HIV and an increasing the amount of CD4 cells in the blood of people with HIV, compared to the amounts of HIV and CD4 cells in people who do not receive treatment at this stage.

Condition or disease

Intervention/treatment

Phase

HIV Infections

Drug: Highly Active Antiretroviral Therapy (HAART)Other: No treatment

Phase 1

Detailed Description:

Antiretroviral (ARV) therapy for the treatment of HIV infection has been remarkably successful in reducing morbidity and mortality in HIV infected people. This treatment still has its shortcomings, however. Individuals receiving ARV treatment are at risk of toxicity, developing drug resistance, and unknown long-term side effects. Therefore, development of alternative treatment strategies is important. A short course of ARV treatment that is initiated during the acute period of HIV infection, followed by treatment cessation may have a substantial impact on controlling infection and delaying the need for lifelong potent ARV therapy. The purpose of this study is to investigate whether treatment initiated during acute HIV infection and followed by a terminal treatment interruption is effective in lowering the viral load set point and raising CD4 cell counts in people with HIV, as compared to those measures in people with HIV who have received no treatment.

Participants in this study will be randomly assigned to one of three groups. Participants in Group A1 will receive ARV therapy for 12 weeks. Participants in Group A2 will receive ARV therapy for 32 weeks. Participants in Group B will not receive any treatment. This study will not provide medications to any of the groups. All groups will be followed for a total of 72 weeks following study entry. Participants will attend between 30 and 36 study visits over the course of the 72 weeks, depending on their study group. Study visits will occur every week for the first 12 weeks and then every 1 to 6 weeks for the remainder of the study. Tests occurring at study visits may include blood tests, investigational immune system tests, and pregnancy tests. Participants will also undergo a complete physical exam and will be asked to provide information about their medical and medication histories.

Study Design

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Study Type :

Interventional (Clinical Trial)

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Clinical Trial to Evaluate the Initiation of Treatment Versus no Treatment During Acute HIV-1 Infection

Study Start Date :

October 2008

Actual Primary Completion Date :

February 7, 2013

Actual Study Completion Date :

July 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

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Arm

Intervention/treatment

Experimental: A1

Antiretroviral therapy followed by discontinuation at Week 12.

Drug: Highly Active Antiretroviral Therapy (HAART)

Participants in Groups A1 and A2 will receive HAART for either 12 or 32 weeks. Their medications will not be provided by the study.

Experimental: A2

Antiretroviral therapy followed by discontinuation at Week 32.

Drug: Highly Active Antiretroviral Therapy (HAART)

Participants in Groups A1 and A2 will receive HAART for either 12 or 32 weeks. Their medications will not be provided by the study.

Placebo Comparator: B

No treatment.

Other: No treatment

Participants in this group will not receive treatment at this stage of their infection.

Outcome Measures

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Primary Outcome Measures :

Difference in the level of HIV RNA at viral load set point if therapy is initiated during acute HIV infection followed by terminal treatment interruption after 12 or 32 weeks of treatment compared to that under no treatment [ Time Frame: Week 72 ]

Secondary Outcome Measures :

Difference in the level of CD4 cells if therapy is initiated during acute HIV infection followed by terminal treatment interruption after 12 or 32 weeks of treatment compared to that under no treatment [ Time Frame: Week 72 ]
Difference in the level of HIV RNA and CD4 cell numbers between therapy initiated during acute HIV infection followed by terminal treatment interruption after at least 12 weeks of treatment and no therapy at 16 weeks after discontinuation of treatment [ Time Frame: Weeks 12 and 16 ]
Difference in the level of HIV at viral load set point and CD4 cell number at 72 weeks after study entry if therapy is initiated during acute HIV infection followed by terminal treatment interruption at 12 weeks versus at 32 weeks [ Time Frame: Week 72 ]

Eligibility Criteria

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 65 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Criteria

Inclusion Criteria:

Acute HIV infection as determined by a positive HIV viral load (at least 5,000 copies of RNA per ml of plasma) and a negative or indeterminate Western Blot test
Certain laboratory values. More information about this criterion can be found in the protocol.
Agrees to use an approved form of contraception

Exclusion Criteria:

Presence of opportunistic infections or AIDS-defining illnesses, unless they are directly attributable to the acute seroconversion illness
Receipt of investigational research agents within 30 days prior to study entry
Receipt of prior experimental HIV vaccines. Individuals who received a saline placebo in a prior HIV vaccine trial are not excluded, provided that they did not receive a sham vector or an adjuvant.
Receipt of immunosuppressive medications or immunomodulators (e.g., cytokine therapy) within the past 6 months. Participants taking corticosteroid nasal spray for allergic rhinitis; topical corticosteroids for acute, uncomplicated dermatitis; or over the counter medications for acute, uncomplicated dermatitis for a period not longer than 14 days will not be excluded.
Current use of prohibited concomitant medications
Current anti-tuberculosis prophylaxis or therapy
Serious illness other than acute HIV infection requiring systemic treatment or hospitalization until either therapy is completed or patient is clinically stable on therapy
Hepatitis B surface antigen positivity within 21 days prior to study entry
Pregnant or breastfeeding

Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705926

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Eric S. Rosenberg, MD

Massachusetts General Hospital, Division of Infectious Diseases

Principal Investigator:

H.T. Banks, PhD

North Carolina State University, College of Physical and Mathematical Sciences

Principal Investigator:

Marie Davidian, PhD

North Carolina State University, Department of Statistics

More Information

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Publications:

Kassutto S, Maghsoudi K, Johnston MN, Robbins GK, Burgett NC, Sax PE, Cohen D, Pae E, Davis B, Zachary K, Basgoz N, D’agata EM, DeGruttola V, Walker BD, Rosenberg ES. Longitudinal analysis of clinical markers following antiretroviral therapy initiated during acute or early HIV type 1 infection. Clin Infect Dis. 2006 Apr 1;42(7):1024-31. Epub 2006 Feb 27.

Kassutto S, Rosenberg ES. Editorial comment: treatment of acute HIV infection–uncertainties about best practice. AIDS Read. 2005 May;15(5):250-1.

Kassutto S, Rosenberg ES. Primary HIV type 1 infection. Clin Infect Dis. 2004 May 15;38(10):1447-53. Epub 2004 Apr 30.

Lacabaratz-Porret C, Urrutia A, Doisne JM, Goujard C, Deveau C, Dalod M, Meyer L, Rouzioux C, Delfraissy JF, Venet A, Sinet M. Impact of antiretroviral therapy and changes in virus load on human immunodeficiency virus (HIV)-specific T cell responses in primary HIV infection. J Infect Dis. 2003 Mar 1;187(5):748-57. Epub 2003 Feb 18.

Malhotra U, Berrey MM, Huang Y, Markee J, Brown DJ, Ap S, Musey L, Schacker T, Corey L, McElrath MJ. Effect of combination antiretroviral therapy on T-cell immunity in acute human immunodeficiency virus type 1 infection. J Infect Dis. 2000 Jan;181(1):121-31.

Responsible Party:

Eric Rosenberg, MD, Investigator of Record, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00705926 History of Changes

Other Study ID Numbers:

R01AI071915 ( U.S. NIH Grant/Contract )
RO1AIO71915 ( Other Grant/Funding Number: NIAID )

First Posted:

June 27, 2008 Key Record Dates

Last Update Posted:

August 31, 2017

Last Verified:

August 2017

Keywords provided by Eric Rosenberg, MD, Massachusetts General Hospital:

Acute Infection
HIV
HAART
Treatment Naive

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression - Full Text View - ClinicalTrials.gov

Research on Effect of Traditional Chinese Medicine (TCM) on Immune Reconstitution of HIV/AIDS Patients After Highly Active Antiretroviral Therapy (HAART) - Full Text View - ClinicalTrials.gov

Research on Effect of Traditional Chinese Medicine (TCM) on Immune Reconstitution of HIV/AIDS Patients After Highly Active Antiretroviral Therapy (HAART)

ClinicalTrials.gov Identifier: NCT00974454

Recruitment Status : Unknown

Verified September 2009 by Guang’anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was: Recruiting

First Posted : September 10, 2009

Last Update Posted : October 29, 2009

Sponsor:

Guang’anmen Hospital of China Academy of Chinese Medical Sciences

Information provided by:

Guang’anmen Hospital of China Academy of Chinese Medical Sciences

Study Description

Go to sections

Brief Summary:

Chinese prescriptions can inhibit viral replication according to the course of viral replication, and the effects is similar to the effect of HAART, and even better than the anti-viral and immune reconstitution of HAART due to its effect on improve immune system function. Over the past decades, many researchers have screened the effective Chinese medicines to treat AIDS.

Condition or disease

Intervention/treatment

Phase

Acquired Immune Deficiency Syndrome VirusHIV Infections

Drug: Fuzheng 2Drug: Placebo

Not Applicable

Detailed Description:

There is no record of AIDS in Chinese medicine, modern clinicians hold that AIDS is linked to TCM theory according to its pathogenesis, character of onset and clinical manifestations. As early as more than 2000 years ago, there were records of immune function in TCM. 2 TCM books recorded that “keep vital Qi, the evil will not invade the body “and” the invasion of evil is caused by the deficiency of vital Qi. Vital Qi summarizes the normal immune system function. Vital Qi is the basic material and physiological function which can eliminate the evil, regulating yin and yang and protect the body.
And this is in accordance with defense, homeostasis and surveillance of immune system in western medicine. The knowledge of immunology has guided medical practice in China for more than two thousand years. In response to a variety of immune diseases, there are various immunotherapy such as Yiqi Fuzheng immunotherapy, reinforce kidney therapy, huoxuehuayu therapy and heat-clearing and detoxifying therapy. Throughout the course of AIDS, the evil (HIV) exists and the vital Qi is turning weak gradually. If we adopted a number of intervention measures to assist the body’s Vital Qi, Vital Qi will be strengthened and the evil will be weakened. Therefore, TCM will play an important role in improving immune function.
Chinese prescriptions can inhibit viral replication according to the course of viral replication, and the effects is similar to the effect of HAART, and even better than the anti-viral and immune reconstitution of HAART due to its effect on improve immune system function. Over the past decades, many researchers have screened the effective Chinese medicines to treat AIDS.

Researchers screened single Chinese herbs, some extract and the effective components of Chinese medicine and prescriptions. Some study the role of its anti-HIV, some study the role of its regulating immunization function. The former studies have shown that immunization 2 (Fuzheng 2) has wide effect on immune system and it can activate the reticuloendothelial system, macrophage phagocytes and lymphocyte transformation. And it can relieve disorders, imbalance of the immune system caused by HIV infection.

In addition, this prescription can inhibit HIV reverse transcription polymerase enzyme and virus-induced syncytium formation, protect virus-infected cells, and inhibit virus replication in HIV-1 infected cells.
Through the clinical trials, we will evaluate the effect of immune 2 (Fuzheng 2) on immune reconstitution of adult HIV/AIDS patients who have received HAART.

Study Design

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Study Type :

Interventional (Clinical Trial)

Estimated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Research on Effect of TCM on Immune Reconstitution of HIV/AIDS Patients After HAART

Study Start Date :

September 2009

Estimated Primary Completion Date :

April 2010

Estimated Study Completion Date :

December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

Go to sections

Arm

Intervention/treatment

Active Comparator: Fuzheng 2

Immunity 2 (Fuzheng 2), 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Drug: Fuzheng 2

Immunity 2 (Fuzheng 2), 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Placebo Comparator: Placebo

Placebo, 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Drug: Placebo

Placebo, 6.25g twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Outcome Measures

Go to sections

Primary Outcome Measures :

Peripheral blood CD3+ CD4+ counts [ Time Frame: 6 months ]

Secondary Outcome Measures :

Immune reconstitution efficiency [ Time Frame: 6 months ]
Viral load [ Time Frame: 6 months ]
Clinical symptoms and signs [ Time Frame: 6 months ]
KPS score [ Time Frame: 6 months ]
Quality of life score [ Time Frame: 6 months ]
Side effects of HAART [ Time Frame: 6 months ]
Safety evaluation [ Time Frame: 6 months ]
Economic evaluation [ Time Frame: 6 months ]

Eligibility Criteria

Go to sections

Information from the National Library of Medicine

Ages Eligible for Study:

18 Years to 70 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Criteria

Inclusion Criteria:

HIV antibody-positive, confirmed by Western Blot test
HIV antibody-positive, confirmed by Western Blot test
HAART ≥ 12 months
CD 4 count increased by <100 cells / ul
HIV RNA <50 c / ml (bDNA);
Age ≥ 18 years old and ≤ 70 years old
Voluntary participated in this study, signed informed consent form, and could be followed-up

Exclusion Criteria:

Serious opportunistic infections were not brought under control (Pneumocystis carinii pneumonia, meningitis, esophageal candidiasis, lymphoma, toxoplasma encephalopathy, tuberculosis, etc.) before the experiment
Participated in clinical trials of other drugs within one month before the experiment
Received immunomodulatory treatment within one month before the experiment
WBC <2 × 10 9 / L, N <1.0 × 10 9 / L, Hb <90g / L, PLT <75 × 10 9 / L,liver and kidney dysfunction (AST, ALT, T-BIL ≥2 times of upper limit of the reference value or creatinine ≥ 2 times of the upper limit of reference value)
Patients with pancreatitis or active gastric ulcer
Patients with obvious active diseases in respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, or genitourinary system diseases
Persons suffering from autoimmune diseases
Cancer patients which need chemotherapy
Pregnant or lactating women, and did not use safe contraceptive measures for women of child-bearing age, as well as the male that can not take a reasonable method of contraception in trial period
Hypersensitive people
Patients with dysgnosia or language barriers, which can not fully understand the test or cooperate well

Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974454

Contacts

Contact: Jie Liu, MD

8610-88001381

dr.liujie@163.com

Locations

China, Beijing

Guang’anmen Hospital of China Academy of Chinese Medical Sciences

Recruiting

Beijing, Beijing, China, 100053

Contact: Jie WANG, MD 8610-88001381 dr.liujie@163.com

Sponsors and Collaborators

Guang’anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

Study Chair:

Jie WANG, MD

Guang’anmen Hospital of China Academy of Chinese Medical Sciences

More Information

Go to sections

Responsible Party:

WANG, Jie/Professor, Guang’anmen Hospital of China Academy of Chinese Medical Sciences

ClinicalTrials.gov Identifier:

NCT00974454 History of Changes

Other Study ID Numbers:

09.07.16-1

First Posted:

September 10, 2009 Key Record Dates

Last Update Posted:

October 29, 2009

Last Verified:

September 2009

Keywords provided by Guang’anmen Hospital of China Academy of Chinese Medical Sciences:

AIDS
complementary therapies
treatment experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

The Effect of Combination of Traditional Chinese Medicine (TCM) and Highly Active Antiretroviral Therapy (HAART) on Immune Reconstitution of HIV/AIDS Patients - Full Text View - ClinicalTrials.gov

The Effect of Combination of Traditional Chinese Medicine (TCM) and Highly Active Antiretroviral Therapy (HAART) on Immune Reconstitution of HIV/AIDS Patients

ClinicalTrials.gov Identifier: NCT00974519

Recruitment Status : Unknown

Verified September 2009 by Guang’anmen Hospital of China Academy of Chinese Medical Sciences.
Recruitment status was: Recruiting

First Posted : September 10, 2009

Last Update Posted : October 29, 2009

Sponsor:

Guang’anmen Hospital of China Academy of Chinese Medical Sciences

Information provided by:

Guang’anmen Hospital of China Academy of Chinese Medical Sciences

Study Description

Go to sections

Brief Summary:

Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The long-term clinical application has proved the safety and effect. It can improve the symptoms and signs in AIDS patients with the effective rate of 70% and can significantly improve the quality of life. It can also improve and stabilize immune function and inhibit viral replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity.

Condition or disease

Intervention/treatment

Phase

Acquired Immune Deficiency Syndrome VirusHIV Infections

Drug: Fuzheng 3Drug: Fuzheng 1Drug: Placebo

Not Applicable

Detailed Description:

Meng Kun found that Joint application of Chuankezhi can enhance the number of CD4 cells and reduce side-effects of HAART compared with HAART alone. in order to verify the long-term efficacy of combination therapy, they carried out an clinical observations of three cases of patients who received combination therapy for over a period of 3 years, through the observation of three cases of patients, they found that CD3+CD4+T lymphocyte count were significantly increased and HIV-RNA viral load were below 50copies for long-term, and without the occurrence of drug resistance. And the patient’s symptoms and signs have also been significantly improved.
Duan Cheng Yu analyses 334 cases of AIDS patients’ clinical symptoms, signs and Karnofsky score, and CD3+CD4+ T lymphocyte count before and after treatment. The patients all take “kang ai bao sheng” capsules for 3 months. The results showed that 334 cases of patients receiving traditional Chinese and western medicine treatment shows improvement in symptoms and signs, increase in CD3+CD4+ T lymphocyte count. They proposed that combination of traditional Chinese and western medicine can improve symptoms, enhance immunity function and improve the quality of life of AIDS patients.
In order to observe the effect of combination of TCM and HAART on HIV/AIDS patients, ZHANG Ai-min divided 63 cases of AIDS into 3 groups. 20 cases received TCM treatment and 22 cases received combination of TCM and HAART, 21 cases received western medicine. The patients’ symptoms, signs, Karnofsky score points, CD3+CD4+T lymphocyte counts and HIV-RNA viral load were recorded and compare the difference between the 3 groups. The results showed that combination treatment can more effectively improve the immune function of HIV/AIDS patients, reduce HIV-RNA viral load, and improve the patients’ symptoms, signs and the quality of life.
Immunity 1 (Fuzheng 1) is composed of herbs which have tonic and detoxific function. The long-term clinical application has proved the safety and effect. It can improve the symptoms and signs in AIDS patients with the effective rate of 70% and can significantly improve the quality of life. It can also improve and stabilize immune function and inhibit viral replication. The basis study have shown that Immunity 1 (Fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of IL-2, IFN-γ, participate in immune regulation effect, enhance NK cell activity, promote CD3+CD4+T cell proliferation and increase macrophage phagocytes capacity.
Through the clinical trials, we are going to evaluate the efficacy and safety of combination of TCM and HAART on immune reconstitution of HIV/AIDS patients.

Study Design

Go to sections

Study Type :

Interventional (Clinical Trial)

Estimated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trials on the Effect of Combination of TCM and HAART on Immune Reconstitution of HIV/AIDS Patients

Study Start Date :

September 2009

Estimated Primary Completion Date :

June 2010

Estimated Study Completion Date :

December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

Go to sections

Arm

Intervention/treatment

Active Comparator: Fuzheng 3

Immunity 3 (Fuzheng 3), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Drug: Fuzheng 3

Immunity 3 (Fuzheng 3), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Immunity 1 (Fuzheng 1) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Active Comparator: Fuzheng 1

Immunity 1 (Fuzheng 1), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Drug: Fuzheng 1

Immunity 1 (Fuzheng 1), 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Placebo Comparator: Placebo

Placebo, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Drug: Placebo

Immunity 1 (Fuzheng 1) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Immunity 3 (Fuzheng 3) simulation agent, 8.75g / twice a day, half an hour before breakfast and dinner, mixing with water, for six successive cycles of 30 days.

Outcome Measures

Go to sections

Primary Outcome Measures :

Peripheral blood CD3+ CD4+ counts [ Time Frame: 6 months ]

Secondary Outcome Measures :

Immune reconstitution efficiency [ Time Frame: 6 months ]
Viral load [ Time Frame: 6 months ]
Clinical symptoms and signs [ Time Frame: 6 months ]
KPS score [ Time Frame: 6 months ]
Quality of life score [ Time Frame: 6 months ]
Side effect of HAART [ Time Frame: 6 months ]
Safety evaluation [ Time Frame: 6 months ]
Economic evaluation [ Time Frame: 6 months ]

Eligibility Criteria

Go to sections

Information from the National Library of Medicine

Ages Eligible for Study:

18 Years to 70 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Criteria

Inclusion Criteria:

HIV antibody-positive, confirmed by Western Blot test
CD 4 count ≤ 350 cells / ul
Age ≥ 18 years old and ≤ 70 years old
Voluntary participated in this study, signed informed consent form, and could be followed-up

Exclusion Criteria:

Serious opportunistic infections were not brought under control (Pneumocystis carinii pneumonia, meningitis, esophageal candidiasis, lymphoma, toxoplasma encephalopathy, tuberculosis, etc.) before the experiment
Participated in clinical trials of other drugs within one month before the experiment
Received antiretroviral therapy or are anti-HIV drugs such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs) and fusion-inhibiting agent (FIs), integrase inhibitors, inhibitors penetration within one month before the experiment
Received immunomodulatory treatment within one month before the experiment WBC <2 × 10 9 / L, N <1.0 × 10 9 / L, Hb <90g / L, PLT <75 × 10 9 / L, liver and kidney dysfunction (AST, ALT, T-BIL ≥2 times of upper limit of the reference value or creatinine ≥ 2 times of the upper limit of reference value)
Patients with pancreatitis or active gastric ulcer
Patients with obvious active diseases in respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, or genitourinary system diseases
Persons suffering from autoimmune diseases
Cancer patients which need chemotherapy
Pregnant or lactating women, and did not use safe contraceptive measures for women of child-bearing age, as well as the male that can not take a reasonable method of contraception in trial period
Hypersensitive people
Patients with dysgnosia or language barriers, which can not fully understand the test or cooperate well

Contacts and Locations

Go to sections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974519

Contacts

Contact: Jie Liu, MD

8610-88001381

dr.liujie@163.com

Locations

China, Beijing

Jie, WANG

Recruiting

Beijing, Beijing, China, 100053

Contact: Jie WANG, MD 8610-88001381 dr.liujie@163.com

Sponsors and Collaborators

Guang’anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

Study Chair:

Jie WANG, MD

Guang’anmen Hospital of China Academy of Chinese Medical Sciences

More Information

Go to sections

Responsible Party:

WANG, Jie/Professor, Guang’anmen Hospital of China Academy of Chinese Medical Sciences

ClinicalTrials.gov Identifier:

NCT00974519 History of Changes

Other Study ID Numbers:

09.07.16-2

First Posted:

September 10, 2009 Key Record Dates

Last Update Posted:

October 29, 2009

Last Verified:

September 2009

Keywords provided by Guang’anmen Hospital of China Academy of Chinese Medical Sciences:

ADIS
complementary therapies

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Lactoferrin Treatment in HIV Patients - Full Text View - ClinicalTrials.gov

Microsoft Word - LactoferrinProtocol_v2.0_CLEAN_25March2015.doc

Lactoferrin Treatment in HIV Patients

ClinicalTrials.gov Identifier: NCT01830595

Recruitment Status : Completed

First Posted : April 12, 2013

Results First Posted : September 18, 2018

Last Update Posted : October 18, 2018

Sponsor:

Jason Baker

Collaborator:

Ventria Bioscience

Information provided by (Responsible Party):

Jason Baker, Hennepin Healthcare Research Institute

Study Description

Go to sections

Brief Summary:

Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.

Condition or disease

Intervention/treatment

Phase

HIV Infection

Drug: Recombinant LactoferrinDrug: Placebo

Phase 2

Study Design

Go to sections

Study Type :

Interventional (Clinical Trial)

Actual Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients

Actual Study Start Date :

September 2014

Actual Primary Completion Date :

July 2017

Actual Study Completion Date :

January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

Go to sections

Arm

Intervention/treatment

Active Comparator: Recombinant Lactoferrin

Recombinant lactoferrin will be administered by mouth twice daily

Drug: Recombinant Lactoferrin

Placebo Comparator: Placebo

Matched placebo will be administered by mouth twice daily

Drug: Placebo

Outcome Measures

Go to sections

Primary Outcome Measures :

Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event [ Time Frame: During 3 months on Lactoferrin or Placebo (and following washout period) ]

Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious)

IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8) [ Time Frame: 3 months (Baseline to Month 3 or Month 5 to Month 8) ]

The IL-6 & D-dimer score is defined as: 0. 33*log2 IL-6 + 0.16*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 & D-dimer score are interpreted as “HR(event) per doubling of IL-6 and D-dimer”, or “HR(event) per 20% increase in IL-6 and D-dimer”; the score itself is unitless.

Among the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5.

Higher scores are worse.

Number of Participants Taking Medication as Assigned [ Time Frame: 3 months ]

Number of participants taking medication as assigned at 3 months

Other Outcome Measures:

Activated Monocyte Phenotype (CD16+) [ Time Frame: 3 months ]

The change in CD16+ monocyte subsets will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).

sCD163 [ Time Frame: 3 months ]

The change in blood levels of sCD163 will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).

Eligibility Criteria

Go to sections

Information from the National Library of Medicine

Ages Eligible for Study:

40 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Criteria

Inclusion Criteria:

HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year
HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values)
Age >40 years

Exclusion Criteria:

Prior cardiovascular disease or stroke
Diabetes
Rheumatologic Diseases
Pregnancy
Chronic kidney disease, stage IV or V (creatinine clearance <30 mL/min/1.73m2)
Cirrhosis or end-stage liver disease

Contacts and Locations

Go to sections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830595

Locations

United States, Minnesota

Hennepin County Medical Center

Minneapolis, Minnesota, United States, 55415

Sponsors and Collaborators

Jason Baker

Ventria Bioscience

Investigators

Principal Investigator:

Jason V Baker, MD, MS

Hennepin Healthcare Research Institute

Study Documents (Full-Text)

Documents provided by Jason Baker, Hennepin Healthcare Research Institute:

Study Protocol, Statistical Analysis Plan, and Informed Consent Form [PDF] March 25, 2015

More Information

Go to sections

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sortino O, Hullsiek KH, Richards E, Rupert A, Schminke A, Tetekpor N, Quinones M, Prosser R, Schacker T, Sereti I, Baker JV. The Effects of Recombinant Human Lactoferrin on Immune Activation and the Intestinal Microbiome Among Persons Living with Human Immunodeficiency Virus and Receiving Antiretroviral Therapy. J Infect Dis. 2019 May 24;219(12):1963-1968. doi: 10.1093/infdis/jiz042.

Responsible Party:

Jason Baker, Associate Professor of Medicine, Hennepin Healthcare Research Institute

ClinicalTrials.gov Identifier:

NCT01830595 History of Changes

Other Study ID Numbers:

PCC-006

First Posted:

April 12, 2013 Key Record Dates

Results First Posted:

September 18, 2018

Last Update Posted:

October 18, 2018

Last Verified:

September 2018

Additional relevant MeSH terms:

HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lactoferrin
Anti-Infective Agents

New Era Study: Treatment With Multi Drug Class (MDC) HAART in HIV Infected Patients - Full Text View - ClinicalTrials.gov

New Era Prüfplan v3.2.2 final

New Era Study: Treatment With Multi Drug Class (MDC) HAART in HIV Infected Patients (NewEra)

ClinicalTrials.gov Identifier: NCT00908544

Recruitment Status : Completed

First Posted : May 27, 2009

Results First Posted : August 28, 2019

Last Update Posted : August 28, 2019

Sponsor:

MUC Research GmbH

Collaborators:

Merck Sharp & Dohme Corp.

AbbVie

Pfizer

German Center for Infection Research

Information provided by (Responsible Party):

MUC Research GmbH

Study Description

Go to sections

Brief Summary:

This is a multi-center, open-label, non-randomized proof-of-concept trial. Two cooperating HIV-specialized centres represented by Dr. med. Hans Jaeger and Prof. Dr. Johannes Bogner are planning to perform an IIT (investigator initiated trial) with the goal to eradicate HIV in N=40 HIV-infected patients with either primary infection or chronic infection and successful HAART (Highly Active Antiretroviral Treatment) of several years.

All patients will be started on a multi-drug HAART including two Nucleoside-Reverse-Transcriptase-Inhibitors (NRTI´s), one Protease-Inhibitor (PI), a CCR5-inhibitor and an Integrase-Inhibitor (INI). Decay of viral reservoirs like latently HIV-infected CD4+ T-cells will be monitored over time.

Condition or disease

Intervention/treatment

Phase

HIV Infections

Other: PHI-patientsOther: CHI-patients

Not Applicable

Show detailed description

Study Design

Go to sections

Study Type :

Interventional (Clinical Trial)

Actual Enrollment :

47 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

NEW ERA STUDY - HIV and Eradication: A Multicenter, Open-label, Non-randomized Trial to Evaluate Treatment With Multi-drug Class (MDC) HAART and Its Impact on the Decay Rate of Latently Infected CD4+ T Cells Incl. Amendment 1.0

Actual Study Start Date :

May 15, 2009

Actual Primary Completion Date :

April 3, 2018

Actual Study Completion Date :

May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Arms and Interventions

Go to sections

Arm

Intervention/treatment

Experimental: PHI-patients

Patients with primary HIV infection (PHI) (see also “Eligibility”) are immediately treated with 2 NRTI + 1 PI/r + Maraviroc + Raltegravir

Other: PHI-patients

Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir

Experimental: CHI-patients

Patients with chronic HIV infection (CHI) and with suppressed plasma viral load for at least three years under continuous HAART (2 NRTI + 1 PI/r see also “Eligibility”) intensified by Maraviroc + Raltegravir

Other: CHI-patients

Treatment intensification of PI-based HAART with Maraviroc and Raltegravir. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir

Outcome Measures

Go to sections

Primary Outcome Measures :

Combined Endpoint Including HIV RNA and HIV DNA [ Time Frame: Screening, month -3 (= pre-baseline only for CHI-patients), baseline, months 1, 3, 6 and then every 6 months until month 84 ]

The primary outcome measure (i.e. achievement of ‘eradication’) is a combined endpoint including cell-associated proviral DNA and plasma HIV RNA and is defined as undetectable cell-associated HIV DNA (copies per 10exp6 PBMC (peripheral blood mononuclear cells) and per 10exp6 CD4 cells) for at least 2 years (measurement by the French ANRS Group) combined with plasma viral load < 50 copies/ml for at least 5 years and undetectable plasma viral load (HIV RNA < 1 copy/ml, 1-copy assay) for at least 2 years.

Secondary Outcome Measures :

Mean Change in HIV DNA in PBMC (Month 36 and Month 84) [ Time Frame: Change from baseline at months 36 and 84 ]

Mean change (CI=95% Confidence Intervall) in HIV DNA copies/10exp6 PBMC (= peripheral blood mononuclear cells) from baseline, to evaluate the decay rates of latently infected cell reservoir.

Mean Change in HIV DNA in CD4+T Cells (Month 36 and Month 84) [ Time Frame: Change from baseline at months 36 and 84 ]

Mean change (CI=95% Confidence Intervall) in HIV DNA copies/10exp6 CD4+T cells from baseline, to evaluate the decay rates of latently infected cell reservoir.

HIV RNA <50 Copies/ml (Proportion) [ Time Frame: Baseline and at months 1, 3, 6 and then every 6 months until month 84 ]

Percentage of patients with Plasma HIV RNA <50 copies/ml at baseline and during follow-up

Median Change in HIV DNA in PBMC Over Time [ Time Frame: Change from baseline at months 1, 3, 6 and then every 6 months until month 84 ]

Median Change from baseline (IQR, interquartile range) in HIV DNA copies/10exp6 PBMC (= peripheral blood mononuclear cells), to evaluate the decay rates of latently infected cell reservoir.

Median Change in HIV DNA in CD4+T Cells Over Time [ Time Frame: Change from baseline at months 1, 3, 6 and then every 6 months until month 84 ]

Median Change from baseline (IQR, interquartile range) in HIV DNA in CD4+T cells, to evaluate the decay rates of latently infected cell reservoir.

Median Change in CD4+T Cells Over Time [ Time Frame: Change from baseline at months 1, 3, 6 and then every 6 months until month 84 ]

Median Change from baseline (IQR, interquartile range) in CD4+T cells/µl.

Median Change in Relative CD4+T Cells Over Time [ Time Frame: Change from baseline at months 1, 3, 6 and then every 6 months until month 84 ]

Median Change from baseline (IQR, interquartile range) in relative CD4+T cells/µl.

Median Change in CD4+/CD8+ Ratio Over Time [ Time Frame: Change form Baseline at months 1, 3, 6 and then every 6 months until month 84 ]

Median change in CD4+/ CD8+ ratio at baseline (IQR, interquartile range) and during follow-up

Median Change in CD8+T Cells Over Time [ Time Frame: Change from baseline at months 1, 3, 6 and then every 6 months until month 84 ]

Median Change from baseline (IQR, interquartile range) in CD8+T cells/µl.

Median Change in CD8+CD38+T Cells Over Time [ Time Frame: Change from baseline at months 1, 3, 6 and then every 6 months until month 84 ]

Median Change from baseline (IQR, interquartile range) in CD8+CD38+T cells/µl.

Absolute HIV DNA in PBMC [ Time Frame: Baseline and at months 1, 3, 6 and then every 6 months until month 84 ]

Absolute HIV DNA in PBMC (= peripheral blood mononuclear cells) from baseline (Median; IQR, interquartile range), to quantify the cell-associated latently infected reservoir size by visit and treatment Group.

Absolute HIV DNA in CD4+T Cells [ Time Frame: Baseline and at months 1, 3, 6 and then every 6 months until month 84 ]

Absolute HIV DNA in CD4+T cells from baseline (Median; IQR, interquartile range), to quantify the cell-associated latently infected reservoir size by visit and treatment Group.

Absolute CD4+T Cells [ Time Frame: Baseline and at months 1, 3, 6 and then every 6 months until month 84 ]

Median CD4+T cells/µl at baseline (IQR, interquartile range) and during follow-up

Relative CD4+T Cells [ Time Frame: Baseline and at months 1, 3, 6 and then every 6 months until month 84 ]

Median relative CD4+T cells/µl at baseline (IQR, interquartile range) and during follow-up

CD4+/CD8+ Ratio [ Time Frame: Baseline and at months 1, 3, 6 and then every 6 months until month 84 ]

Median CD4+/CD8+ ratio at baseline (IQR, interquartile range) and during follow-up

Absolute CD8+T Cells [ Time Frame: Baseline and at months 1, 3, 6 and then every 6 months until month 84 ]

Median CD8+T cells/µl at baseline (IQR, interquartile range) and during follow-up

Absolute CD8+CD38+T Cells [ Time Frame: Baseline and at months 1, 3, 6 and then every 6 months until month 84 ]

Median CD8+CD38+T cells/µl at baseline (IQR, interquartile range) and during follow-up

Eligibility Criteria

Go to sections

Information from the National Library of Medicine

Ages Eligible for Study:

18 Years to 70 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Criteria

Inclusion Criteria:

For all patients:
- HIV-infected patient
- Age greater 18 years
- No acute AIDS-defining disease or history of AIDS- defining disease
- CD4-cell nadir above or equal 200 cells/µL
- Hemoglobin greater 8 g/dl
- Neutrophil count greater 750 cells/µL
- Platelet count greater 50.000 cells/µL
- AST/ALT below 5x upper limit of normal range
- No evidence for drug intolerability
- No prior use of an HIV integrase inhibitor or CCR5 antagonist
- No presence of malignancy (requiring active treatment and malignancy within 5 years prior to enrolment (even if in complete remission)
- No significant underlying disease (non-HIV) that might impinge upon disease progression or death
- No history of alcohol or other substance abuse or other condition which in the opinion of the investigator would interfere with the patient compliance or safety.
- Written informed consent
- For males and premenopausal females use of acceptable methods of birth control during the entire study and for 6 weeks thereafter
- No pregnancy (for premenopausal women: negative serum or urine pregnancy test within 48 hours prior to initiating study medications)
- No breastfeeding
  
  For chronically HIV-infected patients (CHI):
- Continuous plasma viral load below 50 copies/ml for the preceding 36 months under HAART (two or less single viral load blips up to 500 copies/ml are allowed)
- Stable HAART (for at least 3 months) prior to the Screening visit consisting of 2 NRTI + 1 PI
- No history of virological failure
- No documented resistance to PI and NRTI
- CCR5-tropic virus
  
  For patients with primary HIV infection (PHI):
- Detectable plasma viral load
- ELISA positive or negative and Western Blot negative or positive with less or equal 2 bands at screening visit
- No primary resistance to PI´s and NRTI´s
- CCR5-tropic virus
Exclusion criteria:

Evidence for drug intolerability or contraindication concerning any drug foreseen for MDC HAART

Documented HIV-1 resistance to PI and/or NRTI.
CD4 nadir <200/µL
Acute AIDS-defining disease or history of AIDS-defining disease
CHI: preceding virological failure
History of alcohol or other substance abuse or other condition which in the opinion of the investigator would interfere with the patient compliance or safety.
Any of the following abnormal laboratory test results in screening:
1. Hemoglobin < 8 g/dL
2. Neutrophil count < 750 cells/µL
3. Platelet count < 50,000 cells/µL
4. AST or ALT > 5x the upper limit of normal
Presence of malignancy (requiring active treatment and malignancy within 5 years prior to enrolment (even if in complete remission)
Significant underlying disease (non-HIV) that might impinge upon disease progression or death
Prior use of any experimental HIV- Integrase-Inhibitor or CCR5-antagonist.
Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).
Contraindications for Maraviroc (Celsentri®) or Raltegravir (Isentress®) according to the respective summary of product characteristics (see also product informations attached to the protocol) (Hypersensitivity to the active substances or any of the excipients).

Contacts and Locations

Go to sections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908544

Locations

Germany

Onkology Karlsruhe

Karlsruhe, Baden-Wuerttemberg, Germany, 76135

Private Practice for Internal Medicine, Hematology and Oncology

Mannheim, Baden-Wuerttemberg, Germany, 68161

Private Practice Drs Ulmer/Frietsch/Mueller

Stuttgart, Baden-Wuerttemberg, Germany, 70197

Practice Dr. med. Lothar Schneider

Fürth, Bavaria, Germany, 90762

Private Practice Drs Pauli/Becker

Munich, Bavaria, Germany, 80331

MVZ Karlsplatz

Munich, Bavaria, Germany, 80335

University Munich University Hospital, Dept. of Infectious Diseases

Munich, Bavaria, Germany, 80336

ICH Study Center

Hamburg, Germany, 20354

Sponsors and Collaborators

MUC Research GmbH

Merck Sharp & Dohme Corp.

AbbVie

Pfizer

German Center for Infection Research

Investigators

Study Chair:

Hans Jaeger, MD

MUC Research GmbH

Study Chair:

Johannes Bogner, Prof., MD

University Munich, University Hospital, Dept. of Infectious Diseases,

Study Documents (Full-Text)

Documents provided by MUC Research GmbH:

Study Protocol and Statistical Analysis Plan [PDF] November 6, 2014

More Information

Go to sections

Publications of Results:

Grützner EM, Hoffmann T, Wolf E, Gersbacher E, Neizert A, Stirner R, Pauli R, Ulmer A, Brust J, Bogner JR, Jaeger H, Draenert R. Treatment Intensification in HIV-Infected Patients Is Associated With Reduced Frequencies of Regulatory T Cells. Front Immunol. 2018 Apr 30;9:811. doi: 10.3389/fimmu.2018.00811. eCollection 2018.

Other Publications:

Di Mascio M, Dornadula G, Zhang H, Sullivan J, Xu Y, Kulkosky J, Pomerantz RJ, Perelson AS. In a subset of subjects on highly active antiretroviral therapy, human immunodeficiency virus type 1 RNA in plasma decays from 50 to <5 copies per milliliter, with a half-life of 6 months. J Virol. 2003 Feb;77(3):2271-5.

Lehrman G, Hogue IB, Palmer S, Jennings C, Spina CA, Wiegand A, Landay AL, Coombs RW, Richman DD, Mellors JW, Coffin JM, Bosch RJ, Margolis DM. Depletion of latent HIV-1 infection in vivo: a proof-of-concept study. Lancet. 2005 Aug 13-19;366(9485):549-55.

Ramratnam B, Mittler JE, Zhang L, Boden D, Hurley A, Fang F, Macken CA, Perelson AS, Markowitz M, Ho DD. The decay of the latent reservoir of replication-competent HIV-1 is inversely correlated with the extent of residual viral replication during prolonged anti-retroviral therapy. Nat Med. 2000 Jan;6(1):82-5.

Sedaghat AR, Siliciano JD, Brennan TP, Wilke CO, Siliciano RF. Limits on replenishment of the resting CD4+ T cell reservoir for HIV in patients on HAART. PLoS Pathog. 2007 Aug 31;3(8):e122.

Sedaghat AR, Siliciano RF, Wilke CO. Low-level HIV-1 replication and the dynamics of the resting CD4+ T cell reservoir for HIV-1 in the setting of HAART. BMC Infect Dis. 2008 Jan 2;8:2. doi: 10.1186/1471-2334-8-2.

Siliciano JD, Kajdas J, Finzi D, Quinn TC, Chadwick K, Margolick JB, Kovacs C, Gange SJ, Siliciano RF. Long-term follow-up studies confirm the stability of the latent reservoir for HIV-1 in resting CD4+ T cells. Nat Med. 2003 Jun;9(6):727-8. Epub 2003 May 18.

Zhang L, Ramratnam B, Tenner-Racz K, He Y, Vesanen M, Lewin S, Talal A, Racz P, Perelson AS, Korber BT, Markowitz M, Ho DD. Quantifying residual HIV-1 replication in patients receiving combination antiretroviral therapy. N Engl J Med. 1999 May 27;340(21):1605-13.

Henrich TJ, Hanhauser E, Marty FM, Sirignano MN, Keating S, Lee TH, Robles YP, Davis BT, Li JZ, Heisey A, Hill AL, Busch MP, Armand P, Soiffer RJ, Altfeld M, Kuritzkes DR. Antiretroviral-free HIV-1 remission and viral rebound after allogeneic stem cell transplantation: report of 2 cases. Ann Intern Med. 2014 Sep 2;161(5):319-27. doi: 10.7326/M14-1027.

Hütter G, Ganepola S. Eradication of HIV by transplantation of CCR5-deficient hematopoietic stem cells. ScientificWorldJournal. 2011 May 5;11:1068-76. doi: 10.1100/tsw.2011.102.

Persaud D, Gay H, Ziemniak C, Chen YH, Piatak M Jr, Chun TW, Strain M, Richman D, Luzuriaga K. Absence of detectable HIV-1 viremia after treatment cessation in an infant. N Engl J Med. 2013 Nov 7;369(19):1828-35. doi: 10.1056/NEJMoa1302976. Epub 2013 Oct 23.

Sáez-Cirión A, Bacchus C, Hocqueloux L, Avettand-Fenoel V, Girault I, Lecuroux C, Potard V, Versmisse P, Melard A, Prazuck T, Descours B, Guergnon J, Viard JP, Boufassa F, Lambotte O, Goujard C, Meyer L, Costagliola D, Venet A, Pancino G, Autran B, Rouzioux C; ANRS VISCONTI Study Group. Post-treatment HIV-1 controllers with a long-term virological remission after the interruption of early initiated antiretroviral therapy ANRS VISCONTI Study. PLoS Pathog. 2013 Mar;9(3):e1003211. doi: 10.1371/journal.ppat.1003211. Epub 2013 Mar 14.

Responsible Party:

MUC Research GmbH

ClinicalTrials.gov Identifier:

NCT00908544 History of Changes

Other Study ID Numbers:

MUC_NewEra_3.3
2008-002070-35 ( EudraCT Number )
4034932 ( Other Identifier: BfArM )
08101 ( Other Identifier: Bayerische Landesärztekammer )
ID 8879 ( Other Grant/Funding Number: Pfizer )
IISP #35576 ( Other Grant/Funding Number: MSD )

First Posted:

May 27, 2009 Key Record Dates

Results First Posted:

August 28, 2019

Last Update Posted:

August 28, 2019

Last Verified:

August 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by MUC Research GmbH:

HIV-infection
Primary HIV-infection
Proviral DNA
Eradication
Multi drug class HAART

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

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