Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients
- Conditions
- HIV Infections
- Interventions
- Drug: Lopinavir/ritonavir (drug)
- Registration Number
- NCT00140751
- Lead Sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Brief 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
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simplification Lopinavir/ritonavir (drug) The patients included in this arm are on Monotherapy of Kaletra (Lopinavir/ritonavir)during 48 weeks
- Primary Outcome Measures
Name Time Method Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study W48
- Secondary Outcome Measures
Name Time Method Proportion of patients showing a lipodystrophy at J0 and S48 W48 Durability of viral response W48 Evolution of lymphocytes CD4 W48 Observance W48 Clinical and biological tolerance W48 Quantitative and qualitative changes in quality of life data W48 Cost-efficacy ratio W48 Predictive value of proviral DNA before treatment simplification W48
Trial Locations
- Locations (25)
Hôpital Henri Mondor - Service d'Immunologie Clinique
🇫🇷Créteil, France
Hôpital A. Michallon - Service des Maladies Infectieuses
🇫🇷Grenoble, France
Hôpital Nord - CISIH
🇫🇷Marseille, France
Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses
🇫🇷Paris, France
Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie
🇫🇷Paris, France
Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales
🇫🇷Montpellier, France
Hôpital Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales
🇫🇷Fort-de-France, Martinique, France
Centre Hospitalier de la Région Annecienne (CHRA) - Service d'Infectiologie
🇫🇷Annecy, France
Hôpital Jean Verdier - Unité de Maladies Infectieuses
🇫🇷Bondy, France
Hôpital Saint-André - Service de Médecine Interne et Maladies Infectieuses
🇫🇷Bordeaux, France
Hôpital Côte de Nacre - Service des Maladies Infectieuses
🇫🇷Caen, France
Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
🇫🇷Bordeaux, France
Hôpital Bicêtre - Service de Médecine Interne
🇫🇷Le Kremlin-Bicetre, France
Hôpital Saint-André - Service de Médecine Interne et Maladies Tropicales
🇫🇷Bordeaux, France
Hôpital Raymond Poincaré - Service des Maladies Infectieuses et Tropicales
🇫🇷Garches, France
Hôpital Sainte-Marguerite - Unité Médicale CISIH
🇫🇷Marseille, France
Hôpital de l'Archet - Service d'Infectiologie
🇫🇷Nice, France
Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales
🇫🇷Paris, France
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1
🇫🇷Paris, France
Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
🇫🇷Paris, France
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
🇫🇷Paris, France
Hôpital Pontchaillou - Service des Maladies Infectieuses
🇫🇷Rennes, France
Hôpital de Brabois Adultes - Service de Maladies Infectieuses et Tropicales
🇫🇷Vandoeuvre-les-Nancy, France
Hôpital Gustave Dron - Service des Maladies Infectieuses
🇫🇷Tourcoing, France
Hôpital Civil - Hôpital de Jour du CISIH - Clinique Médicale A
🇫🇷Strasbourg, France