Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
|ClinicalTrials.gov Identifier: NCT00051844|
Recruitment Status : Completed
First Posted : January 20, 2003
Last Update Posted : May 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Drug: Capravirine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||179 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||August 2002|
|Actual Study Completion Date :||November 2004|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051844
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