Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects

Study Identifier
M05-730
CT.gov Identifier
EudraCT Identifier
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 (LPV/r) (tablet or capsule) with nucleoside reverse transcriptase inhibitors (NRTIs)
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The purpose of this study was to compare the safety and tolerability of the to-be-marketed

    lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC)

    formulation and to compare the safety, tolerability, and antiviral activity of once daily

    (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select

    nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously

    received antiretroviral treatment.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 823
    Phoenix, Arizona, United States, 85006
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 846
    Phoenix, Arizona, United States, 85012
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 851
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 872
    Fountain Valley, California, United States, 92708
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 826
    Long Beach, California, United States, 90813
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 876
    Newport Beach, California, United States, 92663
    Status
    Not applicable
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