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

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Lopinavir/ritonavir (drug)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00140751

KALESOLO

IMEA-030

Details and patient eligibility

About

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

Full description

Highly active antiretroviral therapy (HAART) has made a significant impact on the natural history of HIV-1 infection, but toxicities and complexities of therapy limit long-term efficacy, and make simpler yet effective HAART regimens highly desirable. Previous attempts to 'de-intensify' protease inhibitor (PI)-based therapy by discontinuing reverse transcriptase inhibitors (RTI) after achieving viral suppression met with failure, probably because plasma levels of most individually administered PI are too low to inhibit viral replication consistently.

Low-dose ritonavir substantially enhances lopinavir plasma levels, and lopinavir/ritonavir (LPV/r) is effective as part of a combination therapy in both naive and PI-experienced patients. Furthermore, lopinavir is known to have a high genetic barrier to selection of resistance. LPV/r monotherapy could thus have the right combination of potency, favorable pharmacokinetics, and high genetic barrier needed to suppress viral replication and prevent the selection of lopinavir resistance. Preliminary results with "maintenance"LPV/r monotherapy show interesting results but data from randomized studies are needed.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Simplification

Experimental group

Description:

The patients included in this arm are on Monotherapy of Kaletra (Lopinavir/ritonavir)during 48 weeks

Treatment:

Drug: Lopinavir/ritonavir (drug)

Continued

No Intervention group

Description:

The patients included in this arm continue their treatment without any changes