A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
- Conditions
- HIV Infections
- Registration Number
- NCT00002235
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
- Detailed Description
Patients receive a treatment regimen consisting of nelfinavir, indinavir, and efavirenz for 48 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. After Week 48, patients with documented virologic response are eligible to continue receiving study treatments and to attend scheduled follow-up visits. Patients who experience virologic failure are discontinued from the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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)
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Univ of Colorado / Health Science Ctr
🇺🇸Denver, Colorado, United States
Pacific Oaks Med Group
🇺🇸Beverly Hills, California, United States
Brown Univ School of Medicine
🇺🇸Providence, Rhode Island, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States