Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen|
- The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks
- when compared to a 3-drug regimen without capravirine in patients who had experienced virologic failure while on a nonnucleoside reverse transcriptase inhibitor regimen.
- The safety and tolerability of 2 doses of capravirine.
- The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics
- The relationship of HIV resistance (genotype and phenotype) to virologic response.
- The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts
- The population pharmacokinetics of capravirine and VIRACEPT
- The pharmacokinetics of potential drug-drug interactions.
|Study Start Date:||August 2002|
|Study Completion Date:||November 2004|
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