Clinical Trial: Immunologic Control of Drug Resistant HIV

This study is no longer recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

Drug resistant HIV strains often develop in patients who have taken anti-HIV drugs for an extended time. However, these drug resistant HIV strains do not always cause an increase in the level of HIV in the blood. This study will explore why some patients with drug resistant virus continue to have low viral loads.

Condition
HIV Infections

MedlinePlus related topics:  AIDS

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

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

Further Study Details: 

Expected Total Enrollment:  50

Study start: March 2003;  Study completion: December 2006
Last follow-up: December 2006;  Data entry closure: December 2006

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • HIV positive 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

Location Information


California
      San Francisco General Hospital, San Francisco,  California,  94110,  United States

Study chairs or principal investigators

Steven G. Deeks, MD,  Study Chair,  Department of Medicine, University of California - San Francisco   

More Information

Study ID Numbers:  1R01AI052745-01
Record last reviewed:  February 2005
Last Updated:  February 11, 2005
Record first received:  January 28, 2003
ClinicalTrials.gov Identifier:  NCT00053404
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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