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)
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
THE Clinic
🇺🇸Los Angeles, California, United States
Maxine Liggins
🇺🇸Los Angeles, California, United States
Summa Health System
🇺🇸Akron, Ohio, United States
Children's Diagnostic Treatment Ctr
🇺🇸Fort Lauderdale, Florida, United States
Community Health Care
🇺🇸Fort Lauderdale, Florida, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
MCP Hahnemann Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Texas Southwestern Med Ctr
🇺🇸Dallas, Texas, United States
Thomas Street Clinic
🇺🇸Houston, Texas, United States
Arizona Clinical Research Ctr Inc
🇺🇸Tucson, Arizona, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Univ TX San Antonio Health Science Ctr
🇺🇸San Antonio, Texas, United States
Good Samaritan Hosp
🇺🇸Los Angeles, California, United States
UCLA Care Ctr
🇺🇸Los Angeles, California, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Immunity Care and Research Inc
🇺🇸Plantation, Florida, United States
South Shore Hosp
🇺🇸Miami, Florida, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
HIV Outpatient Clinics / LA State Univ Med Ctr
🇺🇸New Orleans, Louisiana, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Ponce de Leon Ctr
🇺🇸Atlanta, Georgia, United States
Miriam Hosp
🇺🇸Providence, Rhode Island, United States
Comprehensive Care Center
🇺🇸Fort Lauderdale, Florida, United States
Longbeach Memorial Med Ctr
🇺🇸Longbeach, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
Philip Brachman
🇺🇸Atlanta, Georgia, United States
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
South Jersey Infectious Diseases Inc
🇺🇸Somers Point, New Jersey, United States
WNC Community Health Services
🇺🇸Asheville, North Carolina, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of Missouri at Kansas City School of Medicine
🇺🇸Kansas City, Missouri, United States
Orange County Health Dept
🇺🇸Orlando, Florida, United States
Daniel Seekins
🇺🇸Tampa, Florida, United States
Infectious Disease Research Institute
🇺🇸Tampa, Florida, United States
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States