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

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ClinicalTrials.gov Identifier: NCT00140751

Recruitment Status : Completed

First Posted : September 1, 2005

Last Update Posted : September 19, 2013

Sponsor:

Collaborator:

Abbott

Information provided by (Responsible Party):

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

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

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

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	186 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	October 2005
Actual Primary Completion Date :	January 2008
Actual Study Completion Date :	January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Ritonavir Lopinavir

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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 ]

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 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
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
Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales
Paris, France, 75012
Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
Paris, France, 75013
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1
Paris, France, 75013
Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses
Paris, France, 75014
Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie
Paris, France, 75015
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
Paris, France, 75020
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:

Click here for more information about this study: KALESOLO This link exits the ClinicalTrials.gov site

Publications:

Mocroft A, Ledergerber B, Katlama C, Kirk O, Reiss P, d'Arminio Monforte A, Knysz B, Dietrich M, Phillips AN, Lundgren JD; EuroSIDA study group. Decline in the AIDS and death rates in the EuroSIDA study: an observational study. Lancet. 2003 Jul 5;362(9377):22-9.

Yeni PG, Hammer SM, Hirsch MS, Saag MS, Schechter M, Carpenter CC, Fischl MA, Gatell JM, Gazzard BG, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Schooley RT, Thompson MA, Vella S, Volberding PA. Treatment for adult HIV infection: 2004 recommendations of the International AIDS Society-USA Panel. JAMA. 2004 Jul 14;292(2):251-65.

Bartlett JA, DeMasi R, Quinn J, Moxham C, Rousseau F. Overview of the effectiveness of triple combination therapy in antiretroviral-naive HIV-1 infected adults. AIDS. 2001 Jul 27;15(11):1369-77.

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.

Murphy R, Gazzard B. Antiretroviral treatment guidelines. AIDS. 2003 Jun;17 Suppl 2:S1.

Bucher HC, Kofler A, Nüesch 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.

Drechsler H, Powderly WG. Switching effective antiretroviral therapy: a review. Clin Infect Dis. 2002 Nov 15;35(10):1219-30. Epub 2002 Oct 21. Review.

Martínez E, Conget I, Lozano L, Casamitjana R, Gatell JM. Reversion of metabolic abnormalities after switching from HIV-1 protease inhibitors to nevirapine. AIDS. 1999 May 7;13(7):805-10.

Moyle G, Baldwin C, Mandalia S, Comitis S, Burn P, Gazzard B. Changes in metabolic parameters and body shape after replacement of protease inhibitor With efavirenz in virologically controlled HIV-1-positive persons: single-arm observational cohort. J Acquir Immune Defic Syndr. 2001 Dec 1;28(4):399-401.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Meynard JL, Bouteloup V, Landman R, Bonnard P, Baillat V, Cabie A, Kolta S, Izopet J, Taburet AM, Mercie P, Chene G, Girard PM; KALESOLO Study Group. Lopinavir/ritonavir monotherapy versus current treatment continuation for maintenance therapy of HIV-1 infection: the KALESOLO trial. J Antimicrob Chemother. 2010 Nov;65(11):2436-44. doi: 10.1093/jac/dkq327. Epub 2010 Sep 15.


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
First Posted:	September 1, 2005 Key Record Dates
Last Update Posted:	September 19, 2013
Last Verified:	September 2013

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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir	HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors

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