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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
230
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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
...and 29 more locations