A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
- Conditions
- HIV Infections
- Registration Number
- NCT00002430
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.
- Detailed Description
Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
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 (46)
Emory Univ
🇺🇸Atlanta, Georgia, United States
Tower ID Med Associates
🇺🇸Los Angeles, California, United States
AIDS Community Research Consortium
🇺🇸Redwood City, California, United States
Oak Lawn Physicians Group
🇺🇸Dallas, Texas, United States
Northwestern Univ Med Ctr
🇺🇸Chicago, Illinois, United States
AIDS Consultation Service / Maine Med Ctr
🇺🇸Portland, Maine, United States
JSI Research and Training Institute
🇺🇸Boston, Massachusetts, United States
Saint Francis Mem Hosp / HIV Care Unit
🇺🇸San Francisco, California, United States
Pacific Horizons Med Group
🇺🇸San Francisco, California, United States
Vanderbilt Univ Med Ctr
🇺🇸Nashville, Tennessee, United States
Hillsborough County Health Dept
🇺🇸Tampa, Florida, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
Fanno Creek Clinic
🇺🇸Portland, Oregon, United States
Denver Public Health Dept
🇺🇸Denver, Colorado, United States
Oasis Clinic / King Drew Med Ctr
🇺🇸Los Angeles, California, United States
Robert Scott MD
🇺🇸Oakland, California, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Univ of Alabama School of Med
🇺🇸Montgomery, Alabama, United States
Ocean View Internal Medicine
🇺🇸Long Beach, California, United States
Physicans Home Service
🇺🇸Washington, District of Columbia, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Blick Med Associates
🇺🇸Stamford, Connecticut, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Univ of Illinois
🇺🇸Chicago, Illinois, United States
Thomas Coffman MD
🇺🇸Boise, Idaho, United States
Kaiser Foundation Hospital
🇺🇸San Francisco, California, United States
Harold Katner MD
🇺🇸Macon, Georgia, United States
Infectious Disease Specialists of NJ
🇺🇸Union, New Jersey, United States
Louisiana State Univ Med Ctr / Tulane Med School
🇺🇸New Orleans, Louisiana, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Wake Forest Univ School of Medicine
🇺🇸Winston Salem, North Carolina, United States
Institute of Human Virology
🇺🇸Baltimore, Maryland, United States
Liberty Med Group
🇺🇸New York, New York, United States
James Jones MD
🇺🇸New York, New York, United States
Infections Ltd / Physicians Med Ctr
🇺🇸Tacoma, Washington, United States
Burnside Clinic
🇺🇸Columbia, South Carolina, United States
Chicago Ctr for Clinical Research
🇺🇸Chicago, Illinois, United States
Anderson Clinical Research / Inc
🇺🇸Pittsburgh, Pennsylvania, United States
Associates in Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
Kentucky Clinical Research
🇺🇸Lexington, Kentucky, United States
Brookdale Univ Hosp and Med Ctr
🇺🇸Brooklyn, New York, United States
Community Health Network
🇺🇸Rochester, New York, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Education & Research Building
🇺🇸Camden, New Jersey, United States
NJCRI
🇺🇸Newark, New Jersey, United States
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States