HIV in Specific Parts of the Body of Patients Who Are Changing or Starting Potent Anti-HIV Drugs
NCT ID: NCT00007488
Last Updated: 2013-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
164 participants
OBSERVATIONAL
2000-11-30
2004-08-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Alejo Erice
Role: STUDY_CHAIR
Robert Coombs
Role: STUDY_CHAIR
Susan Fiscus
Role: STUDY_CHAIR
Locations
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Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
Willow Clinic
Menlo Park, California, United States
Univ of California, San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Univ of California San Francisco
San Francisco, California, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States
Stanford Univ Med Ctr
Stanford, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Emory Univ
Atlanta, Georgia, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
The CORE Ctr
Chicago, Illinois, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
Washington Univ / St Louis Connect Care
St Louis, Missouri, United States
Washington Univ School of Medicine
St Louis, Missouri, United States
Community Health Network Inc
Rochester, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States
Univ of Washington
Seattle, Washington, United States
Countries
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References
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Kantor R, Bettendorf D, Bosch RJ, Mann M, Katzenstein D, Cu-Uvin S, D'Aquila R, Frenkel L, Fiscus S, Coombs R; ACTG A5077 Study Team. HIV-1 RNA levels and antiretroviral drug resistance in blood and non-blood compartments from HIV-1-infected men and women enrolled in AIDS clinical trials group study A5077. PLoS One. 2014 Apr 3;9(4):e93537. doi: 10.1371/journal.pone.0093537. eCollection 2014.
Other Identifiers
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AACTG A5077
Identifier Type: -
Identifier Source: secondary_id
ACTG A5077
Identifier Type: -
Identifier Source: secondary_id
A5077
Identifier Type: -
Identifier Source: org_study_id