Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00002234
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
- Detailed Description
Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, patients with documented virologic response are eligible to continue receiving study treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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 (5)
Pacific Oaks Med Group
🇺🇸Beverly Hills, California, United States
Univ of Colorado / Health Science Ctr
🇺🇸Denver, Colorado, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Brown Univ School of Medicine
🇺🇸Providence, Rhode Island, United States