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

Moore, CL; Stohr, W; Crook, AM; Richert, L; Lelievre, J-D; Pantaleo, G; Garcia, F; ... McCormack, S; + view all (2019) Multi-arm, multi-stage randomised controlled trials for evaluating therapeutic HIV cure interventions. Lancet HIV , 6 (5) e334-e340. 10.1016/S2352-3018(19)30082-7. Green open access

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Abstract

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.

Type: Article
Title: Multi-arm, multi-stage randomised controlled trials for evaluating therapeutic HIV cure interventions
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/S2352-3018(19)30082-7
Publisher version: https://doi.org/10.1016/S2352-3018(19)30082-7
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: Antiretroviral therapy, Clinical trials, Designs, Efficacy, Immunology, Infection, Infectious Diseases, Outcomes, Transmission, Treatment Interruption, Vaccines, Viral Load
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10075579
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