Immunologic Control of Drug Resistant HIV

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00053404
First received: January 28, 2003
Last updated: September 25, 2008
Last verified: September 2008

January 28, 2003
September 25, 2008
March 2003
December 2006   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00053404 on ClinicalTrials.gov Archive Site
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Not Provided
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Immunologic Control of Drug Resistant HIV
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood collection

Non-Probability Sample

HIV-infected participants receiving antiretroviral therapy

HIV Infections
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Emu B, Sinclair E, Favre D, Moretto WJ, Hsue P, Hoh R, Martin JN, Nixon DF, McCune JM, Deeks SG. Phenotypic, functional, and kinetic parameters associated with apparent T-cell control of human immunodeficiency virus replication in individuals with and without antiretroviral treatment. J Virol. 2005 Nov;79(22):14169-78.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2008
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053404
1R01AI052745-01, 1 R01AI052745-01
Not Provided
Steven G. Deeks, MD, Department of Medicine, University of California - San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Steven G. Deeks, MD Department of Medicine, University of California - San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP