The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation

Study Identifier
P15-452
CT.gov Identifier
NCT02581202
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol and Statistical Analysis Plan
Available Language(s): English
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Human Immunodeficiency Virus (HIV)
    • Study Drug
  • lopinavir/ritonavir
  • lamivudine
    • Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Age 18 years and older (male and female). 2. HIV-1 infected patients on any triple HAART with plasma HIV-1 RNA level \<50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r + 3TC) no more than 60 days ago. 3. Cumulative HAART experience at least 6 months. 4. Authorization (Consent) for Use/Disclosure of Data signed by the patient.
    Exclusion Criteria:
    1. Contraindications to lopinavir/ritonavir and lamivudine 2. Previous participation in this program

    Protocol Summary

    This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the Russian Federation.

    Study Locations

    No locations found.