Immunologic Control of Drug Resistant HIV
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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
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Condition or disease |
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HIV Infections |
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 |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV-infected for at least 6 months prior to study entry
- Documented pretherapy or off-therapy viral load of more than 10,000 copies/ml on at least 2 occasions or more than 20,000 copies/ml on at least 1 occasion
- At least a 70% reduction in plasma HIV RNA levels from pretherapy baseline
- Stable highly active antiretroviral therapy (HAART) regimen for at least 4 months prior to study entry
- HIV viral load of 200 to 10,000 copies/ml for 3 months prior to study entry
- CD4 count greater than 100 cells/mm3 and a nadir CD4 count less than 500 cells/mm3
- Virologic failure as defined by DHHS guidelines on at least one HAART regimen prior to the study entry HAART regimen
- Documented adherence to antiretroviral therapy
- Two major resistance mutations to at least two antiretroviral drug classes
Exclusion Criteria:
- Significant toxicity on current HAART regimen

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Publications of Results:
Responsible Party: | Steven G. Deeks, MD, Department of Medicine, University of California - San Francisco |
ClinicalTrials.gov Identifier: | NCT00053404 History of Changes |
Other Study ID Numbers: |
1R01AI052745-01 ( U.S. NIH Grant/Contract ) |
First Posted: | January 29, 2003 Key Record Dates |
Last Update Posted: | September 26, 2008 |
Last Verified: | September 2008 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced Drug Resistance |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |