Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
- Conditions
- HIV Infections
- Registration Number
- NCT00008554
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.
- Detailed Description
Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
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 (23)
Ocean View Internal Medicine
🇺🇸Long Beach, California, United States
Saint Michael's Med Ctr
🇺🇸Newark, New Jersey, United States
Hillsborough County Health Dept
🇺🇸Tampa, Florida, United States
Howard Grossman
🇺🇸New York, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
Brookdale Univ Hosp and Med Ctr
🇺🇸Brooklyn, New York, United States
Florida ID Group
🇺🇸Orlando, Florida, United States
Clinical Pharmacology Services
🇺🇸Tampa, Florida, United States
Univ of Rochester Med Ctr
🇺🇸Rochester, New York, United States
East Bay Clinical Trial Ctr
🇺🇸Concord, California, United States
Veterans Affairs Med Ctr of North Chicago
🇺🇸Chicago, Illinois, United States
Univ of Texas Med Branch
🇺🇸Galveston, Texas, United States
Univ of Kansas Med Ctr
🇺🇸Kansas City, Kansas, United States
Gervais Frechette
🇺🇸New York, New York, United States
Addiction Research and Treatment Corp
🇺🇸Brooklyn, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
SMO-USA Inc
🇺🇸Charlotte, North Carolina, United States
Advanced Clinical Trials Inc
🇺🇸Eugene, Oregon, United States
Thomas Jefferson Univ
🇺🇸Philadelphia, Pennsylvania, United States
Southwest Texas Methodist Hosp
🇺🇸San Antonio, Texas, United States
MacGregor Med Association
🇺🇸Houston, Texas, United States
Walter Gaman
🇺🇸Irving, Texas, United States
UMDNJ - New Jersey Med School
🇺🇸Newark, New Jersey, United States