Immunologic Control of Drug Resistant HIV
|ClinicalTrials.gov Identifier: NCT00053404|
Recruitment Status : Unknown
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was: Active, not recruiting
First Posted : January 29, 2003
Last Update Posted : September 26, 2008
|Condition or disease|
Despite the emergence of high level drug resistance in HIV-infected patients on stable antiretroviral therapy, plasma HIV RNA levels generally remain below the pretherapy viral load "set-point". The virologic and immunologic determinants of this lower steady state level of viremia have not been defined. Preliminary data indicate that: 1) drug resistant variants have reduced replicative capacity and pathogenic potential; 2) drug resistant viremia is associated with reduced T cell activation and turnover compared to wild-type viremia; and 3) patients with low level drug resistant viremia often have HIV-specific CD4 cells that are absent in patients with higher levels of viremia. This study will investigate whether the emergence of a poorly fit, drug resistant variant results in the generation of an effective HIV-specific CD4 cell response and if this response contributes to the establishment of a lower steady state level of viremia.
Participants in this study will be followed for 2 years or until antiretroviral therapy is modified or discontinued. Study visits will occur every 2 months, for a total of 14 visits. Study visits will include a patient interview and blood tests to measure the breadth and magnitude of the HIV-specific CD4 and CD8 cell responses as a function of viral load, viral replicative capacity, drug resistance phenotype, T cell turnover, and thymic function.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Observational Study of HIV Infected Adults With Detectable Plasma HIV-1 RNA Levels Between 200 and 10,000 Copies/mL While Receiving Stable Antiretroviral Therapy|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||December 2006|
|Estimated Study Completion Date :||December 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053404
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Study Chair:||Steven G. Deeks, MD||Department of Medicine, University of California - San Francisco|