A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00005106
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.
- Detailed Description
Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
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 (39)
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Arizona Clinical Research Ctr Inc
🇺🇸Tucson, Arizona, United States
Longbeach Memorial Med Ctr
🇺🇸Longbeach, California, United States
Good Samaritan Hosp
🇺🇸Los Angeles, California, United States
THE Clinic
🇺🇸Los Angeles, California, United States
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States
Maxine Liggins
🇺🇸Los Angeles, California, United States
UCLA Care Ctr
🇺🇸Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
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