A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002374
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.
- Detailed Description
Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) \>= 5,000-30,000 HIV-1 RNA, 2) \> 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors \[RTIs\]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Pacific Oaks Med Ctr
🇺🇸Beverly Hills, California, United States
Tower Infectious Diseases / Med Associates Inc
🇺🇸Los Angeles, California, United States
Community Research Initiative of South Florida
🇺🇸Coral Gables, Florida, United States
Ctr for Quality Care
🇺🇸Tampa, Florida, United States
Community Research Initiative of New England
🇺🇸Brookline, Massachusetts, United States
AIDS Ctr
🇺🇸New York, New York, United States
Anderson Clinical Research / Inc
🇺🇸Pittsburgh, Pennsylvania, United States
Pacific Oaks Med Ctr🇺🇸Beverly Hills, California, United States