HIV in Specific Parts of the Body of Patients Who Are Changing or Starting Potent Anti-HIV Drugs

November 19, 2013 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Virologic Studies in Compartmental Samples From HIV-Infected Subjects Changing or Initiating Potent Antiretroviral Therapy

The purpose of this study is to gain information on how the type and amount of HIV present in certain places in the body and in the blood are affected when potent (powerful) anti-HIV drugs are given.

Researchers know that the type and amount of HIV may differ in certain places in the body (called compartments) but are not sure how anti-HIV treatment affects these differences. This study gathers information to help understand how the virus grows and changes between blood and nonblood compartments in patients receiving anti-HIV treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

The goal of antiretroviral therapy is maximal suppression of HIV-1 replication. Yet studies show that there is ongoing replication of latent virus in the blood and lymphoid tissues of some patients receiving potent antiretroviral therapy who have had suppressed plasma HIV-1 RNA levels for prolonged periods of time. This continued viral persistence and replication could eventually result in virologic failure and clinical progression as well as selection and transmission of resistant HIV-1. There is a need to identify, quantify, and determine significance of viral reservoirs in compartments other than blood. A5077 is designed to evaluate the relationship between viral load in blood and nonblood compartments and time to virologic failure in patients initiating or changing potent antiretroviral therapy.

Patients contribute samples of blood at study entry (prior to changing or initiating potent antiretroviral therapy), Week 8 and every 8 weeks thereafter until Week 96, and (if applicable) within 30 days of confirmed virologic failure. Samples of saliva and either genital secretions or lymphoid tissue, or both, are collected at study entry (prior to changing or initiating potent antiretroviral therapy), Weeks 16, 48, and 96, and within 30 days of confirmed virologic failure. Clinical assessments and medication updates are done at study visits. Blood samples are tested for HIV-1 genotypic resistance studies, HIV-1 proviral DNA studies, and HIV-1 quantitation. If total blood volumes exceed safe limits, blood samples will not be drawn for A5077 but the A5077 protocol team will request access to plasma and PBMC samples from any coenrolled study if applicable.

Study Type

Observational

Enrollment

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 900331079
        • Univ of Southern California / LA County USC Med Ctr
      • Menlo Park, California, United States, 94025
        • Willow Clinic
      • San Diego, California, United States, 92103
        • Univ of California, San Diego
      • San Francisco, California, United States, 94110
        • Univ of California San Francisco
      • San Francisco, California, United States, 941104206
        • University of California San Francisco
      • Stanford, California, United States, 943055107
        • San Mateo AIDS Program / Stanford Univ
      • Stanford, California, United States, 943055107
        • Stanford Univ Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Univ
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612
        • The CORE Ctr
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ of Minnesota
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington Univ / St Louis Connect Care
      • St Louis, Missouri, United States, 63108
        • Washington Univ School Of Medicine
    • New York
      • Rochester, New York, United States, 14642
        • Univ of Rochester Medical Center
      • Rochester, New York, United States, 14642
        • Community Health Network Inc
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997215
        • Univ of North Carolina
    • Ohio
      • Columbus, Ohio, United States, 432101228
        • Ohio State Univ Hosp Clinic
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Brown Univ / Miriam Hosp
      • Providence, Rhode Island, United States, 02906
        • Miriam Hosp / Brown Univ
    • Washington
      • Seattle, Washington, United States, 98104
        • Univ of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are at least 13 years old.
  • Are HIV-positive.
  • Are changing or beginning anti-HIV therapy (not provided by the study). Anti-HIV therapy should be an approved 3-drug combination.
  • Have a viral load of at least 2,000 copies/ml within 60 days of study entry.
  • Have signed consent of parent or guardian if under 18 years of age.
  • Are willing to contribute samples of blood, saliva, and either genital fluids or lymph tissue, or both, at study visits.
  • Are willing to give permission to allow records from any coenrolled studies to be used while participating in this study.
  • Have a negative pregnancy test within 14 days of study entry, if women able to have children. Women who become pregnant while on the study are allowed only to contribute blood and saliva samples until the pregnancy ends. After the pregnancy has ended, collection of genital fluids and/or lymphoid tissue will continue.
  • Agree to receive HIV-related care at an AACTG site, if not enrolled in another AACTG trial.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have had any active opportunistic (AIDS-related) infection or disease, or have another illness occurring at the same time, or other infections, including an active lower genital tract infection that requires a new drug or change in drug in 14 days or less before study entry. There may be an exception for some conditions.
  • Have used immunomodulatory agents in 14 days or less before study entry.
  • Have had an immunization in 14 days or less before study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Alejo Erice
  • Study Chair: Robert Coombs
  • Study Chair: Susan Fiscus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Completion (Actual)

August 1, 2004

Study Registration Dates

First Submitted

December 23, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

November 20, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5077
  • AACTG A5077
  • ACTG A5077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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