Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients
NCT ID: NCT00140751
Last Updated: 2013-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
186 participants
INTERVENTIONAL
2005-10-31
2008-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Simplification
The patients included in this arm are on Monotherapy of Kaletra (Lopinavir/ritonavir)during 48 weeks
Lopinavir/ritonavir (drug)
Continued
The patients included in this arm continue their treatment without any changes
No interventions assigned to this group
Interventions
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Lopinavir/ritonavir (drug)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
OTHER
Responsible Party
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Principal Investigators
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Jean-Luc MEYNARD, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales (Paris, France)
Locations
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Hôpital Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales
Fort-de-France, Martinique, France
Centre Hospitalier de la Région Annecienne (CHRA) - Service d'Infectiologie
Annecy, , France
Hôpital Jean Verdier - Unité de Maladies Infectieuses
Bondy, , France
Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
Bordeaux, , France
Hôpital Saint-André - Service de Médecine Interne et Maladies Infectieuses
Bordeaux, , France
Hôpital Saint-André - Service de Médecine Interne et Maladies Tropicales
Bordeaux, , France
Hôpital Côte de Nacre - Service des Maladies Infectieuses
Caen, , France
Hôpital Henri Mondor - Service d'Immunologie Clinique
Créteil, , France
Hôpital Raymond Poincaré - Service des Maladies Infectieuses et Tropicales
Garches, , France
Hôpital A. Michallon - Service des Maladies Infectieuses
Grenoble, , France
Hôpital Bicêtre - Service de Médecine Interne
Le Kremlin-Bicêtre, , France
Hôpital Nord - CISIH
Marseille, , France
Hôpital Sainte-Marguerite - Unité Médicale CISIH
Marseille, , France
Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales
Montpellier, , France
Hôpital de l'Archet - Service d'Infectiologie
Nice, , France
Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales
Paris, , France
Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
Paris, , France
Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1
Paris, , France
Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses
Paris, , France
Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie
Paris, , France
Hôpital Tenon - Service des Maladies Infectieuses et Tropicales
Paris, , France
Hôpital Pontchaillou - Service des Maladies Infectieuses
Rennes, , France
Hôpital Civil - Hôpital de Jour du CISIH - Clinique Médicale A
Strasbourg, , France
Hôpital Gustave Dron - Service des Maladies Infectieuses
Tourcoing, , France
Hôpital de Brabois Adultes - Service de Maladies Infectieuses et Tropicales
Vandœuvre-lès-Nancy, , France
Countries
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References
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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. doi: 10.1016/s0140-6736(03)13802-0.
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. doi: 10.1001/jama.292.2.251.
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. doi: 10.1097/00002030-200107270-00006.
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.
Murphy R, Gazzard B. Antiretroviral treatment guidelines. AIDS. 2003 Jun;17 Suppl 2:S1. doi: 10.1097/00002030-200306002-00001. No abstract available.
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.
Drechsler H, Powderly WG. Switching effective antiretroviral therapy: a review. Clin Infect Dis. 2002 Nov 15;35(10):1219-30. doi: 10.1086/343050. Epub 2002 Oct 21.
Martinez 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. doi: 10.1097/00002030-199905070-00009.
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. doi: 10.1097/00126334-200112010-00016. No abstract available.
Lambert-Niclot S, Grude M, Meynard JL, Marcelin AG, Valantin MA, Flandre P, Izopet J, Moinot L, Bouteloup V, Calvez V, Katlama C, Girard PM, Morand-Joubert L. Ultrasensitive Human Immunodeficiency Virus Type 1 Viral Load as a Marker of Treatment Choice for Simplification Strategies. Clin Infect Dis. 2018 Nov 28;67(12):1883-1889. doi: 10.1093/cid/ciy382.
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.
Related Links
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Click here for more information about this study: KALESOLO
Other Identifiers
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KALESOLO
Identifier Type: -
Identifier Source: secondary_id
IMEA-030
Identifier Type: -
Identifier Source: org_study_id