HIV in Specific Parts of the Body of Patients Who Are Changing or Starting Potent Anti-HIV Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00007488
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (23)
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
Scroll for more (13 remaining)Univ of Southern California / LA County USC Med Ctr🇺🇸Los Angeles, California, United States