Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Collaborator:
Abbott
Information provided by:
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
ClinicalTrials.gov Identifier:
NCT00140751
First received: August 30, 2005
Last updated: April 5, 2007
Last verified: April 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Lopinavir/ritonavir (drug) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba:
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
| Estimated Enrollment: | 180 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | November 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 | |
| Hôpital-Fondation Saint-Joseph - Service des Maladies Infectieuses | |
| Paris, France, 75014 | |
| Groupe Hospitalier Pitié-Salpêtrière - Service de Médecine Interne 1 | |
| Paris, France, 75013 | |
| Hôpital Tenon - Service des Maladies Infectieuses et Tropicales | |
| Paris, France, 75020 | |
| Hôpital Européen Georges Pompidou (HEGP) - Département d'Immunologie | |
| Paris, France, 75015 | |
| Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales | |
| Paris, France, 75013 | |
| 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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00140751 History of Changes |
| Other Study ID Numbers: | IMEA-030, KALESOLO |
| Study First Received: | August 30, 2005 |
| Last Updated: | April 5, 2007 |
| Health Authority: | France: Ministry of Health |
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 Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013