Safety and Effectiveness of a New Protease Inhibitor, BMS-232632, in HIV-Positive Patients Who Have Received Previous Treatment
The purpose of this study is to look at the safety and effectiveness of an experimental protease inhibitor (a type of anti-HIV drug) called BMS-232632. Doctors will compare an anti-HIV drug combination that includes BMS-232632 to a drug combination that includes ritonavir.
|Study Design:||Endpoint Classification: Safety Study
Primary Purpose: Treatment
|Official Title:||Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, BMS-232632, in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects|
|Study Start Date:||December 1999|
|Study Completion Date:||January 2002|
|Primary Completion Date:||January 2002 (Final data collection date for primary outcome measure)|
This is a three-arm study; patients are randomized to receive BMS-232632 at two different doses or RTV in combination with SQV and two nucleoside analogues over 48 weeks. Randomization is stratified for baseline phenotypic sensitivity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004584
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