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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier:
NCT00140751
First received: August 30, 2005
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
HIV Infections
Drug: Lopinavir/ritonavir (drug)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:

Primary Outcome Measures:
  • Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study [ Time Frame: W48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Durability of viral response [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • Evolution of lymphocytes CD4 [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • Observance [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • Clinical and biological tolerance [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • Quantitative and qualitative changes in quality of life data [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • Cost-efficacy ratio [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • Predictive value of proviral DNA before treatment simplification [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • Proportion of patients showing a lipodystrophy at J0 and S48 [ Time Frame: W48 ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: October 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140751

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

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier: NCT00140751     History of Changes
Other Study ID Numbers: IMEA-030, KALESOLO
Study First Received: August 30, 2005
Last Updated: September 18, 2013
Health Authority: France: Ministry of Health

Keywords provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
HIV-1
Treatment simplification
Lopinavir/ritonavir
Treatment Experienced
HIV Seropositivity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014