The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-21

Study Completion Date

2017-05-27

Brief Summary

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This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1) infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at least 6 months) at the 48 week time point of treatment in the routine clinical settings of the 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

PROSPECTIVE

Study Groups

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HIV-1 infected participants

HIV-1-infected participants on any triple highly active antiretroviral therapy (HAART) with plasma HIV-1 ribonucleic acid (RNA) level \< 50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to lopinavir with ritonavir plus lamivudine (LPV/r+3TC) as decided by the physician in the routine clinical settings. Or HIV-1 infected participants who were switched on the dual therapy (LPV/r+3TC) no more than 60 days prior to enrollment.

lopinavir/ritonavir

Intervention Type DRUG

tablet

lamivudine

Intervention Type DRUG

tablet

Interventions

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lopinavir/ritonavir

tablet

Intervention Type DRUG

lamivudine

tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years and older (male and female).
2. HIV-1 infected patients on any triple HAART with plasma HIV-1 RNA level \<50 copies/mL for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically appropriate to LPV/r + 3TC as decided by the physician in the routine clinical settings. Or HIV-1 infected patients who were switched on the dual therapy (LPV/r + 3TC) no more than 60 days ago.
3. Cumulative HAART experience at least 6 months.
4. Authorization (Consent) for Use/Disclosure of Data signed by the patient.