Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

Study Identifier
ITAL-04-002
CT.gov Identifier
NCT00234910
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Human Immunodeficiency Virus (HIV)
    • Study Drug
  • Tenofovir DF
  • lopinavir/ritonavir with 2 Nucleoside RTIs
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - HIV positive - >18 years of age - HIV RNA> 400 copies/mL - Any CD 4 cell count - Antiretroviral naïve - No acute illness
    Exclusion Criteria:
    -

    Protocol Summary

    The purpose of this study is to obtain a preliminary assessment of the antiviral activity and

    tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection,

    relative to a Kaletra three drug standard of care reference arm.

    Study Locations

    Location
    Status
    Location
    Global Medical Information-Abbott
    Abbott Park, Illinois, United States, 60064
    Status
    Not applicable