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 Overview
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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.

Official Title
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Multi-Center Observational Study to Assess Effectiveness and Safety of Fixed Dose Combination of Generic Product of Lopinavir/Ritonavir in HIV-1 Infected Patients After Switching From Kaletra® (Lopinavir/Ritonavir) for Administrative Reasons in the Routine Clinical Settings of Russian Federation (COPI)

Conditions
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HIV-1 Infection

Participation Criteria
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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. Exclusion Criteria: Participant has contraindications for the treatment with LPV/r. Legal or physical incapability of patient to sign Inform Consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Human Immunodeficiency Virus-1 Infection<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | From 48 Weeks Prior to Enrollment through 48 Weeks Post Enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | Up to Week 48 | 
| Percentage of Participants With Reasons For Switching From Generic LPV/r To Other Antiretroviral Therapy (ART) For HIV Therapy OR Change In The Dosing Regimen | Percentage of participants with different reasons for switching from generic LPV/r to other products of Antiretroviral Therapy (ART) for HIV therapy or change in the dosing regimen - medical reason (infectiveness, intolerance/toxicity, other), non-medical reasons (lack of availability of generic LPV/r, other) and other reasons. | Up to Week 48 | 
| Percentage of Participants Who Develop HIV Drug Resistance Of Generic LPV/r Treatment | Percentage of participants who develop resistance to each drug will be presented. | Up to Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lopinavir/ritonavir (LPV/r), Kaletra, Human Immunodeficiency Virus (HIV), Generic Product, Highly Active Anti-Retroviral Therapy (HAART)