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Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for Which the HIV Reservoir is Low to Moderate
In the early 2000s, the "TRILEGE©" study was realized to determine if the reductive anti retroviral strategy from an initial triple therapy (based on a protease inhibitor as the third agent) towards a dual therapy of nucleoside analogs (in particular the association of "zidovudine +lamivudine") for patients infected by HIV and stabilized for at least 3 months at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic viral load, with an aim to reduce the long-term side effects of the treatment. The afore mentioned study showed that the reductive anti retroviral strategy was a failure. No study has as yet to revaluate this strategy, in particular in the current context of antiretroviral treatments. Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as a superior intrinsic power as compared to treatments proposed in the initial "TRILEGE©" study. Furthermore, the better quality of current triple therapy (as compared to that used 10 years ago) has lead to substantial viral reservoir reduction. Currently, a small number of patients is being successfully treated in the long-term (viral load \< 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of these patients have yet to be thoroughly investigated. The patients concerned were all treated prematurely before ever passing below 200 lymphocytes T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by HIV DNA quantification (\< 2,7 log copies/106 PBMC). Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA value and (3) a very good observance, the investigators emit the hypothesis that, reductive anti retroviral strategy that would consist in changing from a conventional triple therapy towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable control of viral replication with the concomitant benefice of reduced antiretroviral side effects and cost.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Unité des Maladies Infectieuses, CHU de CAEN
Caen, France
Service des Maladies Infectieuses, CHR Orléans La Source, ORLEANS CEDEX 2
CHR d'ORLEANS, France
Service d'Immunologie Clinique centre de Vaccination anti- VIH ANRS Hopital Henri- Mondor
Créteil, France
Service de Médecine Interne et Maladies Infectieuses, Groupe Hospitalier La Rochelle, Cedex 01
La Rochelle, France
Service de Pneumologie, centre Hospitalier Fontenoy, CH de CHARTRES
Le Coudray, France
CHU de NANCY
Nancy, France
Service des maladies Infectieuses et tropicales, CH GEORGES RENON
Niort, France
Service des Maladies Infectieuses et tropicales, APHP SAINT LOUIS
Paris, France
Hospital Tenon
Paris, France
Centre de diagnostic et thérapeutique, Hopital Hotel Dieu
Paris, France
Start Date
December 1, 2014
Primary Completion Date
August 23, 2017
Completion Date
September 21, 2018
Last Updated
December 26, 2025
224
ACTUAL participants
triple therapy
DRUG
dual therapy
DRUG
Lead Sponsor
University Hospital, Tours
Collaborators
NCT07071623
NCT01875588
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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