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

August 30, 2005
September 18, 2013
October 2005
January 2008   (final data collection date for primary outcome measure)
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 ]
Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study
Complete list of historical versions of study NCT00140751 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - Durability of viral response
  • - Evolution of lymphocytes CD4
  • - Observance
  • - Clinical and biological tolerance
  • - Quantitative and qualitative changes in quality of life data
  • - Cost-efficacy ratio
  • - Predictive value of proviral DNA before treatment simplification
  • - Proportion of patients showing a lipodystrophy at J0 and S48
Not Provided
Not Provided
 
Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Lopinavir/ritonavir (drug)
  • Experimental: Simplification
    The patients included in this arm are on Monotherapy of Kaletra (Lopinavir/ritonavir)during 48 weeks
    Intervention: Drug: Lopinavir/ritonavir (drug)
  • No Intervention: Continued
    The patients included in this arm continue their treatment without any changes

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00140751
IMEA-030, KALESOLO
Not Provided
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Abbott
Principal Investigator: Jean-Luc MEYNARD, MD, PhD Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales (Paris, France)
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP