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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Lopinavir/ritonavir (drug)
Sponsored by
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Treatment simplification, Lopinavir/ritonavir, Treatment Experienced, HIV Seropositivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales
  • Centre Hospitalier de la Région Annecienne (CHRA) - Service d'Infectiologie
  • Hôpital Jean Verdier - Unité de Maladies Infectieuses
  • Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
  • Hôpital Saint-André - Service de Médecine Interne et Maladies Infectieuses
  • Hôpital Saint-André - Service de Médecine Interne et Maladies Tropicales
  • Hôpital Côte de Nacre - Service des Maladies Infectieuses
  • Hôpital Henri Mondor - Service d'Immunologie Clinique
  • Hôpital Raymond Poincaré - Service des Maladies Infectieuses et Tropicales
  • Hôpital A. Michallon - Service des Maladies Infectieuses
  • Hôpital Bicêtre - Service de Médecine Interne
  • Hôpital Nord - CISIH
  • Hôpital Sainte-Marguerite - Unité Médicale CISIH
  • Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales
  • Hôpital de l'Archet - Service d'Infectiologie
  • Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales
  • Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
  • Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1
  • Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses
  • Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie
  • Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
  • Hôpital Pontchaillou - Service des Maladies Infectieuses
  • Hôpital Civil - Hôpital de Jour du CISIH - Clinique Médicale A
  • Hôpital Gustave Dron - Service des Maladies Infectieuses
  • Hôpital de Brabois Adultes - Service de Maladies Infectieuses et Tropicales

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Simplification

Continued

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2005
Last Updated
September 18, 2013
Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00140751
Brief Title
Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients
Acronym
KALESOLO
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Collaborators
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Treatment simplification, Lopinavir/ritonavir, Treatment Experienced, HIV Seropositivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simplification
Arm Type
Experimental
Arm Description
The patients included in this arm are on Monotherapy of Kaletra (Lopinavir/ritonavir)during 48 weeks
Arm Title
Continued
Arm Type
No Intervention
Arm Description
The patients included in this arm continue their treatment without any changes
Intervention Type
Drug
Intervention Name(s)
Lopinavir/ritonavir (drug)
Primary Outcome Measure Information:
Title
Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study
Time Frame
W48
Secondary Outcome Measure Information:
Title
Durability of viral response
Time Frame
W48
Title
Evolution of lymphocytes CD4
Time Frame
W48
Title
Observance
Time Frame
W48
Title
Clinical and biological tolerance
Time Frame
W48
Title
Quantitative and qualitative changes in quality of life data
Time Frame
W48
Title
Cost-efficacy ratio
Time Frame
W48
Title
Predictive value of proviral DNA before treatment simplification
Time Frame
W48
Title
Proportion of patients showing a lipodystrophy at J0 and S48
Time Frame
W48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc MEYNARD, MD, PhD
Organizational Affiliation
Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales (Paris, France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales
City
Fort-de-France
State/Province
Martinique
ZIP/Postal Code
97261
Country
France
Facility Name
Centre Hospitalier de la Région Annecienne (CHRA) - Service d'Infectiologie
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
Hôpital Jean Verdier - Unité de Maladies Infectieuses
City
Bondy
ZIP/Postal Code
93143
Country
France
Facility Name
Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Saint-André - Service de Médecine Interne et Maladies Infectieuses
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Saint-André - Service de Médecine Interne et Maladies Tropicales
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Côte de Nacre - Service des Maladies Infectieuses
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital Henri Mondor - Service d'Immunologie Clinique
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital Raymond Poincaré - Service des Maladies Infectieuses et Tropicales
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Hôpital A. Michallon - Service des Maladies Infectieuses
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Hôpital Bicêtre - Service de Médecine Interne
City
Le Kremlin-Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital Nord - CISIH
City
Marseille
ZIP/Postal Code
13020
Country
France
Facility Name
Hôpital Sainte-Marguerite - Unité Médicale CISIH
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Hôpital de l'Archet - Service d'Infectiologie
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hôpital Pontchaillou - Service des Maladies Infectieuses
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Hôpital Civil - Hôpital de Jour du CISIH - Clinique Médicale A
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hôpital Gustave Dron - Service des Maladies Infectieuses
City
Tourcoing
ZIP/Postal Code
59200
Country
France
Facility Name
Hôpital de Brabois Adultes - Service de Maladies Infectieuses et Tropicales
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

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12853195
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PubMed Identifier
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Citation
Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60. doi: 10.1056/NEJM199803263381301.
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PubMed Identifier
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Bucher HC, Kofler A, Nuesch R, Young J, Battegay M, Opravil M. Meta-analysis of randomized controlled trials of simplified versus continued protease inhibitor-based antiretroviral therapy in HIV-1-infected patients. AIDS. 2003 Nov 21;17(17):2451-9. doi: 10.1097/00002030-200311210-00007.
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Links:
URL
http://www.imea.fr/
Description
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Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients

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