The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
- Conditions
- HIV Infections
- Registration Number
- NCT00002371
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.
- Detailed Description
Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain \>= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
SUNY at Stony Brook / Division of Infectious Diseases
🇺🇸Stony Brook, New York, United States
Montreal Gen Hosp / Div of Clin Immuno and Allergy
🇨🇦Montreal, Quebec, Canada
Houston Clinical Research Network / Div of Montrose Clinic
🇺🇸Houston, Texas, United States
Sunnybrook Health Science Ctr
🇨🇦North York, Ontario, Canada
Univ of Puerto Rico School of Medicine
🇵🇷San Juan, Puerto Rico
Univ of South Florida
🇺🇸Tampa, Florida, United States
Univ of Utah / School of Medicine / Div of Infect Dis
🇺🇸Salt Lake City, Utah, United States