Immunologic Control of Drug Resistant HIV

Status unconfirmed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00053404

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

50

Starts

2003-03-01

Expected to finish

2008-12-01

Last updated by the study team

2008-09-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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