Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
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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.
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
Study Start Date :
Actual Study Completion Date :
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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.
Secondary Outcome Measures :
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female at least 18 years old
HIV RNA level >1000 copies/mL at screening
CD4 >50 cells/uL at screening
Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen