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

September 18, 2013 updated by: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

A 48-Weeks National Multicenter Randomized Open Clinical Trial Evaluating Tolerance and Efficacy of a Treatment Simplification by Lopinavir/Ritonavir Versus Continuation of Current Treatment in HIV-Infected Patients With a Viral Load Inferior to 50 Copies/mL Since 6 Months At Least

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France, 74000
        • Centre Hospitalier de la Région Annecienne (CHRA) - Service d'Infectiologie
      • Bondy, France, 93143
        • Hôpital Jean Verdier - Unité de Maladies Infectieuses
      • Bordeaux, France, 33000
        • Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
      • Bordeaux, France, 33000
        • Hôpital Saint-André - Service de Médecine Interne et Maladies Infectieuses
      • Bordeaux, France, 33000
        • Hôpital Saint-André - Service de Médecine Interne et Maladies Tropicales
      • Caen, France, 14033
        • Hôpital Côte de Nacre - Service des Maladies Infectieuses
      • Créteil, France, 94010
        • Hôpital Henri Mondor - Service d'Immunologie Clinique
      • Garches, France, 92380
        • Hôpital Raymond Poincaré - Service des Maladies Infectieuses et Tropicales
      • Grenoble, France, 38000
        • Hôpital A. Michallon - Service des Maladies Infectieuses
      • Le Kremlin-Bicetre, France, 94275
        • Hôpital Bicêtre - Service de Médecine Interne
      • Marseille, France, 13020
        • Hôpital Nord - CISIH
      • Marseille, France, 13274
        • Hôpital Sainte-Marguerite - Unité Médicale CISIH
      • Montpellier, France, 34000
        • Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales
      • Nice, France, 06200
        • Hôpital de l'Archet - Service d'Infectiologie
      • Paris, France, 75020
        • Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
      • Paris, France, 75012
        • Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales
      • Paris, France, 75013
        • Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
      • Paris, France, 75013
        • Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1
      • Paris, France, 75014
        • Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie
      • Rennes, France, 35000
        • Hôpital Pontchaillou - Service des Maladies Infectieuses
      • Strasbourg, France, 67000
        • Hôpital Civil - Hôpital de Jour du CISIH - Clinique Médicale A
      • Tourcoing, France, 59200
        • Hôpital Gustave Dron - Service des Maladies Infectieuses
      • Vandoeuvre-les-Nancy, France, 54511
        • Hôpital de Brabois Adultes - Service de Maladies Infectieuses et Tropicales
    • Martinique
      • Fort-de-France, Martinique, France, 97261
        • Hôpital Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Simplification
The patients included in this arm are on Monotherapy of Kaletra (Lopinavir/ritonavir)during 48 weeks
Drug: Lopinavir/ritonavir (drug)
No Intervention: Continued
The patients included in this arm continue their treatment without any changes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study
Time Frame: W48
W48

Secondary Outcome Measures

Outcome Measure
Time Frame
Durability of viral response
Time Frame: W48
W48
Evolution of lymphocytes CD4
Time Frame: W48
W48
Observance
Time Frame: W48
W48
Clinical and biological tolerance
Time Frame: W48
W48
Quantitative and qualitative changes in quality of life data
Time Frame: W48
W48
Cost-efficacy ratio
Time Frame: W48
W48
Predictive value of proviral DNA before treatment simplification
Time Frame: W48
W48
Proportion of patients showing a lipodystrophy at J0 and S48
Time Frame: W48
W48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Abbott

Investigators

  • Principal Investigator: Jean-Luc MEYNARD, MD, PhD, Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales (Paris, France)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2013

Last Update Submitted That Met QC Criteria

September 18, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMEA-030
  • KALESOLO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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