Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects

Study Identifier
M01-384
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Human Immunodeficiency Virus (HIV)
  • Study Drug
  • Lopinavir/ritonavir
  • Saquinavir mesylate
  • Lamivudine/zidovudine
  • Phase
    CSR.ORG
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    AHF Research
    Los Angeles, California, United States, 90015
    Status
    Not applicable
    Location
    Stephen Becker, MD
    San Francisco,, California, United States, 94115
    Status
    Not applicable
    Location
    Pacific Horizon Medical Group
    San Francisco, California, United States, 94115
    Status
    Not applicable
    Location
    Harbor UCLA, Research & Education Institute
    Torrance, California, United States, 90502
    Status
    Not applicable
    Location
    Community Research Initiative of New England
    Boston,, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    Community Research Initiative of New England
    Springfield, Massachusetts, United States, 01107
    Status
    Not applicable
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