The objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine BID.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
AHF Research
Los Angeles, California, United States
Pacific Horizon Medical Group
San Francisco, California, United States
Stephen Becker, MD
San Francisco, California, United States
Harbor UCLA, Research & Education Institute
Torrance, California, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
Community Research Initiative of New England
Springfield, Massachusetts, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Ottawa at the Ottawa Health Research Institute
Ottawa, Canada
...and 1 more locations
Proportion of subjects with plasma HIV RNA level below 50 copies/mL
Time frame: 48 weeks
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