Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and tolerance of a treatment simplification by a Lopinavir/ritonavir monotherapy versus continuation of current treatment in HIV-infected patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
• Collaborator: Abbott
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• Age > or = 18 years

• Confirmed HIV-1 seropositivity

• Antiretroviral treatment stable since 3 months at least

• HIV-1 ARN load < 50 copies/mL since 6 months at least

• Signed consent form

• No history of treatment failure (= viral load > 1000 copies/mL) including a protease inhibitor

• No opportunistic infection in the previous 6 months

Exclusion Criteria:

• Neutrophils < 750/mm3

• Hemoglobin < 8 g/dL

• Platelets < 60,000/mm3

• Creatinin > 150 micromoles/L

• SGOT > 5 NUL (Normal Upper Limit)

• SGPT > 5 NUL

• Current IL-2 treatment

• HBV infection treated or not by lamivudine or tenofovir

• Pregnancy or feeding

• Enrollment in another study not compliant with KALESOLO Study group assignment