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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-07-08

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Participants with Human Immunodeficiency Virus-1 Infection

Human Immunodeficiency Virus-1 (HIV-1) infected and clinically stable patients on dual or triple HAART including Kaletra who switched or planned to switch to generic product of lopinavir/ritonavir

No interventions assigned to this group

Eligibility Criteria

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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.