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

AbbVie

Status: Completed

Conditions: HIV-1 Infection

Treatments: Drug: lamivudine; Drug: lopinavir/ritonavir

Study type: Observational

Funder types: Industry

Identifiers

NCT02581202

P15-452

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

1. Contraindications to lopinavir/ritonavir and lamivudine
2. Previous participation in this program

Trial design

216 participants in 1 patient group

HIV-1 infected participants

Description:

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.

Treatment:

Drug: lamivudine

Drug: lopinavir/ritonavir