Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV
- Conditions
- Unspecified human immunodeficiency virus [HIV] disease-B24 Unspecified human immunodeficiency virus [HIV] diseaseB24
- Registration Number
- PER-062-03
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Virological failure to 2 or more regimens of highly active antiretroviral therapy (HAART) that, in total, included at least one drug of all classes approved protease inhibitors, non-nucleoside reverse transcriptase inhibitors, nucleoside transcriptase inhibitors reverse.
16 years old to over.
Subjects must be able to provide written informed consent; Subjects must be available for follow-up for a period of at least 48 weeks.
Laboratory baseline values were measured within 2 weeks prior to the start of study drugs.
Previous use (> 3 days) of atazanavir, TVF or LPV / RTV; if the history of SQV, then it must be phenotypically sensitive the antiretroviral regimen that fails currently must have been administered for at least eight weeks at the beginning of the screening and should not include both an IP and an NNRTI
Presence of a newly diagnosed HIV-related opportunistic infection or any medical treatment that requires acute treatment at the time of enrollment
Acute hepatitis proven or suspected within 30 days prior to study entry. Subjects with chronic hepatitis are eligible as long as their liver function enzymes (ALT / AST) are <3 x ULN
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method