Status:
TERMINATED
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
Lead Sponsor:
AbbVie
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- Participant has contraindications for the treatment with LPV/r.
- Legal or physical incapability of patient to sign Inform Consent form
Key Trial Info
Start Date :
November 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT04138199
Start Date
November 1 2019
End Date
July 8 2020
Last Update
July 6 2021
Active Locations (10)
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1
Rep. Cen. of AIDS Profilactis /ID# 216292
Kazan', Tatarstan, Respublika, Russia, 420097
2
Rep Center for the Prev and Control of AIDS and Inf Dis of the MoH of Chuvashia /ID# 216479
Cheboksary, Russia, 428003
3
Reg Ctr for AIDS /ID# 216288
Chelyabinsk, Russia, 454052
4
Reg Ctr for AIDS /ID# 216295
Krasnoyarsk, Russia, 660049