A Study to Compare Two Anti-HIV Drug Combinations
- Conditions
- HIV Infections
- Registration Number
- NCT00002447
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The purpose of this study is to compare 2 anti-HIV drug combinations.
- Detailed Description
Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
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 (26)
UCSF - San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Saint Michael's Med Ctr / Dept of Infectious Diseases
🇺🇸Newark, New Jersey, United States
Associates in Research
🇺🇸Fort Myers, Florida, United States
Joseph Gathe
🇺🇸Houston, Texas, United States
East Carolina Univ School of Medicine
🇺🇸Greenville, North Carolina, United States
Lehigh Valley Hosp
🇺🇸Allentown, Pennsylvania, United States
Burnside Clinic
🇺🇸Columbia, South Carolina, United States
Univ of Utah
🇺🇸Salt Lake City, Utah, United States
Univ of Washington / AIDS Clinical Trial Unit
🇺🇸Seattle, Washington, United States
Univ of Alabama at Birmingham / AIDS Outpatient Clinic
🇺🇸Birmingham, Alabama, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
LIJMC
🇺🇸New Hyde Park, New York, United States
Illinois Masonic Med Ctr
🇺🇸Chicago, Illinois, United States
Toronto Gen Hosp
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de la Universite de Montreal (CHUM)
🇨🇦Montreal, Quebec, Canada
Univ of Miami / Jackson Memorial Hosp
🇺🇸Miami, Florida, United States
Nicholas Bellos
🇺🇸Dallas, Texas, United States
Saint Paul's Hosp
🇨🇦Vancouver, British Columbia, Canada
Physicans Home Service
🇺🇸Washington, District of Columbia, United States
Ponce Univ Hosp
🇵🇷Ponce, Puerto Rico
St Mary's Med Ctr
🇺🇸Long Beach, California, United States
Elmhurst Hosp
🇺🇸Elmhurst, New York, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Infectious Disease Specialists of NJ
🇺🇸Union, New Jersey, United States
Queens Hospital Center
🇺🇸Jamaica, New York, United States