A Study to Assess Effectiveness and Safety of Fixed Dose Combination of Lopinavir/Ritonavir (LPV/r) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients After Switching From Kaletra in the Routine Clinical Settings of Russian Federation

Study Identifier
P20-097
CT.gov Identifier
NCT04138199
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Human Immunodeficiency Virus Type-1 (HIV-1) infected patients on any dual or triple Highly Active Anti-Retroviral Therapy (HAART) with Kaletra under observation at least 48 weeks and with two consequent plasma HIV-1 RNA levels within the last 24 weeks (plasma HIV-1 RNA level \<50 copies/mL) switched to a generic LPV/r as decided by the physician in the routine clinical settings within last 24 weeks from study enrollment date. * HIV-1 infected patients with last available CD4+ T-cell count test result \> 200 cells/mm3 before switching from Kaletra. * Other (not LPV/r) HAART medicine components of dual or triple HIV therapy not planned to change by regular physician after switching to generic LPV/r. * Signed Inform Consent form by patient.
    Exclusion Criteria:
    * Participant has contraindications for the treatment with LPV/r. * Legal or physical incapability of patient to sign Inform Consent form

    Protocol Summary

    This is a mixed prospective-retrospective, multi-center observational study to assess the virologic effectiveness of generic product of Lopinavir/Ritonavir (LPV/r) after switching from Kaletra in the routine clinical settings of Russian Federation.

    Study Locations

    Location
    Status
    Location
    Rep. Cen. of AIDS Profilactis /ID# 216292
    Kazan', Tatarstan, Respublika, Russian Federation, 420097
    Status
    Not applicable
    Location
    Rep Center for the Prev and Control of AIDS and Inf Dis of the MoH of Chuvashia /ID# 216479
    Cheboksary, Russian Federation, 428003
    Status
    Not applicable
    Location
    Reg Ctr for AIDS /ID# 216288
    Chelyabinsk, Russian Federation, 454052
    Status
    Not applicable
    Location
    Reg Ctr for AIDS /ID# 216295
    Krasnoyarsk, Russian Federation, 660049
    Status
    Not applicable
    Location
    Ctr for AIDS Rostov /ID# 216289
    Rostov-on-Don, Russian Federation, 344006
    Status
    Not applicable
    Location
    Samara region HIV/AIDS Center /ID# 216290
    Samara, Russian Federation, 443029
    Status
    Not applicable
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