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NCT00140751 Clinical Trial

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

HIV Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00140751
Other study ID # IMEA-030
Secondary ID KALESOLO
Status Completed
Phase Phase 3
First received August 30, 2005
Last updated September 18, 2013
Start date October 2005
Est. completion date January 2008

Study information
Verified date September 2013
Source Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 186
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lopinavir/ritonavir (drug)

Locations
Country Name City State
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 Pierre Zobda-Quitman - Service de Maladies Infectieuses et Tropicales Fort-de-France Martinique
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-Bicetre
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 Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales Paris
France Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1 Paris
France Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie Paris
France Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales Paris
France Hôpital Tenon - Service des Maladies Infectieuses et Tropicales Paris
France Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses 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 Vandoeuvre-les-Nancy

Sponsors (2)
Lead Sponsor Collaborator
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba Abbott

Country where clinical trial is conducted

France, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study W48 No
Secondary Durability of viral response W48 No
Secondary Evolution of lymphocytes CD4 W48 No
Secondary Observance W48 No
Secondary Clinical and biological tolerance W48 No
Secondary Quantitative and qualitative changes in quality of life data W48 No
Secondary Cost-efficacy ratio W48 No
Secondary Predictive value of proviral DNA before treatment simplification W48 No
Secondary Proportion of patients showing a lipodystrophy at J0 and S48 W48 No
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