A Study of Two Anti-HIV Drug Combinations
- Conditions
- HIV Infections
- Registration Number
- NCT00002203
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.
Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
- Detailed Description
It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.
Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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 (7)
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
Univ of North Carolina Hosps
🇺🇸Chapel Hill, North Carolina, United States
Pacific Oaks Med Ctr
🇺🇸Beverly Hills, California, United States
Tower Infectious Diseases / Med Associates Inc
🇺🇸Los Angeles, California, United States
San Juan AIDS Program
🇵🇷Santurce, Puerto Rico
Univ of Wisconsin School of Medicine
🇺🇸Madison, Wisconsin, United States
Infectious Diseases Physicians Inc
🇺🇸Annandale, Virginia, United States