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
For general inquiries, please contact
Study Complete
Results Available
Scientific Result Summary
Available Language(s): English
Study Details
Medical Condition
Study Drug
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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