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
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2003
CompletedFirst Posted
Study publicly available on registry
January 29, 2003
CompletedStudy Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedSeptember 26, 2008
September 1, 2008
3.8 years
January 28, 2003
September 25, 2008
Conditions
Keywords
Eligibility Criteria
HIV-infected participants receiving antiretroviral therapy
You may qualify if:
- 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
You may not qualify if:
- Significant toxicity on current HAART regimen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco General Hospital
San Francisco, California, 94110, United States
Related Publications (1)
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. doi: 10.1128/JVI.79.22.14169-14178.2005.
PMID: 16254352RESULT
Biospecimen
Blood collection
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Steven G. Deeks, MD
Department of Medicine, University of California - San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
Study Record Dates
First Submitted
January 28, 2003
First Posted
January 29, 2003
Study Start
March 1, 2003
Primary Completion
December 1, 2006
Study Completion
December 1, 2008
Last Updated
September 26, 2008
Record last verified: 2008-09