Safety and Effectiveness of Giving Adefovir Dipivoxil Plus Abacavir Plus Efavirenz Plus Amprenavir to HIV-Infected Patients Who Have Failed to Respond to Previous Protease Inhibitor Treatment
- Conditions
- HIV Infections
- Registration Number
- NCT00002419
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The purpose of this study is to see if it is safe and effective to give adefovir dipivoxil plus abacavir (ABC) plus efavirenz (EFV) plus amprenavir (APV) to HIV-infected patients who have failed to respond to previous treatment with protease inhibitors (PIs).
- Detailed Description
Patients receive a treatment regimen of adefovir dipivoxil, abacavir, efavirenz, and amprenavir for 24 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. Patients who experience virologic failure are discontinued from the study. After Week 24, patients with documented virologic response are eligible to continue receiving the study treatment and to attend scheduled follow-up visits.
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)
Brown Univ School of Medicine
🇺🇸Providence, Rhode Island, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Pacific Oaks Med Group
🇺🇸Beverly Hills, California, United States
Univ of Colorado / Health Science Ctr
🇺🇸Denver, Colorado, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States