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

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
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- Percentage of patients with a viral load < 50 copies/mL at S48 without any modification of antiretroviral treatment during study [ Time Frame: W48 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Jean-Luc MEYNARD, MD, PhD | Hôpital Saint-Antoine - Service des Maladies Infectieuses et Tropicales (Paris, France) |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |