Immunologic Control of Drug Resistant HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
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 or disease
HIV Infections

Detailed Description:

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Biospecimen Retention:   Samples With DNA
Blood collection

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected participants receiving antiretroviral therapy

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00053404

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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 Identifier: NCT00053404     History of Changes
Other Study ID Numbers: 1R01AI052745-01 ( U.S. NIH Grant/Contract )
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