Multi-arm, multi-stage randomised controlled trials for evaluating therapeutic HIV cure interventions.

Détails

ID Serval
serval:BIB_2A5E5DD64601
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Multi-arm, multi-stage randomised controlled trials for evaluating therapeutic HIV cure interventions.
Périodique
The lancet. HIV
Auteur(s)
Moore C.L., Stöhr W., Crook A.M., Richert L., Leliévre J.D., Pantaleo G., García F., Vella S., Lévy Y., Thiébaut R., McCormack S.
ISSN
2352-3018 (Electronic)
ISSN-L
2352-3018
Statut éditorial
Publié
Date de publication
05/2019
Peer-reviewed
Oui
Volume
6
Numéro
5
Pages
e334-e340
Langue
anglais
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't ; Review
Publication Status: ppublish
Résumé
The evaluation of immune-based approaches to achieve an antiretroviral therapy free remission of HIV infection requires proven efficacy through antiretroviral therapy interruption placebo-controlled trials. This approach is not without risk to participants and innovative trial designs need to be developed that minimise the number of participants treated with placebo and ineffective candidates. Multi-arm, multi-stage (MAMS) trial designs can be used in this context to accelerate the development of an immune-based therapeutic agent for HIV cure. Issues related to implementing a MAMS design within the planned EHVA T01 trial are considered here. EHVA T01 is a multicentre, MAMS, double-blind, phase 1 and 2 trial that aims to evaluate the effect of immune interventions on viral control in HIV-1 infected participants following analytic treatment interruption. The application of a MAMS design increases the likelihood that the EHVA T01 trial will identify a successful treatment and minimises the number of participants undergoing analytical treatment interruptions who have been treated with futile agents. The use of a MAMS design is a promising strategy to evaluate complex immune-based approaches aimed at curing HIV-infection, particularly relevant to the pipeline with multiple agents requiring examination.
Mots-clé
Anti-Retroviral Agents/pharmacology, Anti-Retroviral Agents/therapeutic use, Antiretroviral Therapy, Highly Active, HIV Infections/drug therapy, HIV Infections/virology, HIV-1/drug effects, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Research Design, Treatment Outcome
Pubmed
Web of science
Création de la notice
09/05/2019 9:51
Dernière modification de la notice
23/06/2020 5:21
Données d'usage