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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00007488
First received: December 23, 2000
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Official Title: Virologic Studies in Compartmental Samples From HIV-Infected Subjects Changing or Initiating Potent Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 164
Study Start Date: November 2000
Study Completion Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007488

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00007488     History of Changes
Other Study ID Numbers: A5077, AACTG A5077, ACTG A5077
Study First Received: December 23, 2000
Last Updated: November 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV-1
Lymphoid Tissue
Viremia
RNA, Viral
Saliva
Anti-HIV Agents
Viral Load
Genitalia, Female
Genitalia, Male

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014