Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients

Study Identifier
FRAN-03-001
CT.gov Identifier
NCT00234923
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, English
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Study Details

Medical Condition
  • Human Immunodeficiency Virus (HIV)
    • Study Drug
  • lopinavir/ritonavir
  • lamivudine/zidovudine
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Antiretroviral naïve - HIV RNA <100,000 copies/mL - CD4 cell count >100 cells/mL at screening - with Karnofsky Score > 70 - If female, - non-pregnant and - not breastfeeding - No AIDS opportunistic infection within 30 days of screening
    Exclusion Criteria:
    - Subject with an HIV primo-infection status - Recent history of drug and/or alcohol abuse - History of psychiatric illness - If presence of the following mutations : - in the protease : one among 32,47,48,50,82,84,90 - OR more than 3 mutations from the other points of the LPV mutation score:10,20,24,46,53,54,63,71 - in the reverse transcriptase : 215 or 184. - If abnormal laboratory results such as : - Hb<8 g/dl - Absolute neutrophil count<750 cells/µl - Platelet count<50 000/ml

    Protocol Summary

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

    activity and tolerability of Kaletra single agent therapy as initial treatment for HIV

    infection, relative to a Kaletra three drug standard of care reference arm

    Study Locations

    No locations found.