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

AbbVie239 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

239

Conditions

HIV-1 Infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Rep. Cen. of AIDS Profilactis /ID# 216292

Kazan', Tatarstan, Respublika, Russia

Rep Center for the Prev and Control of AIDS and Inf Dis of the MoH of Chuvashia /ID# 216479

Cheboksary, Russia

Reg Ctr for AIDS /ID# 216288

Chelyabinsk, Russia

Outcomes

Primary Outcomes

Percentage of Participants Who Meet HIV-1- RNA Viral Load >50 Copies/mL, OR CD4+ T-Cell Counts < 200 Cells/mm^3

Percentage of participants who meet at least one of the following composite endpoint criteria : HIV-1- Ribonucleic Acid (RNA) viral load \>50 copies/mL, OR Cluster of differentiation 4 (CD4+) T-cell counts \< 200 cells/mm3.

Time frame: Up to 48 Weeks

Indicator of Participants Who Have a Development of New or Recurrent Opportunistic Infections or HIV-Associated Malignancies OR any SAE Associated With HIV Treatment

Percentage of participants who meet at least one of the following composite endpoint criteria: Development of new or recurrent opportunistic infections or HIV-associated malignancies (based on physician observation and decision), OR Any Serious Adverse Event (SAE), associated with HIV treatment.

Time frame: From 48 Weeks Prior to Enrollment through 48 Weeks Post Enrollment

Secondary Outcomes

Time to Failure

Percentage of participants who meet at least one of the following composite endpoint criteria: HIV-1- RNA viral load \>50 copies/ml, OR CD4+ T-cell counts \< 200 cells/mm3, OR development of new or recurrent opportunistic infections or HIV-associated malignancies (based on physician observation and decision), OR any Serious Adverse Event (SAE), associated with HIV treatment.

Time frame: Up to Week 48

Change in HIV-1- RNA Viral Load Compared To The Last Measure On Kaletra Treatment

Untransformed (Absolute) and Base-10 Logarithm Transformed Data Values of HIV-1- RNA Viral Load and The Change As Compared To The Last Measure On Kaletra Treatment

Time frame: Up to Week 48

Change in CD4+ T-cell Counts Compared To The Last Measure On Kaletra Treatment

Absolute values of CD4+ T-cell counts the change as compared to the last measure on Kaletra treatment will be summarized with descriptive statistics.

Data from ClinicalTrials.gov

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