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

Cecilia L. Moore, Wolfgang Stöhr, Angela M. Crook, Laura Richert, Jean Daniel Leliévre, Giuseppe Pantaleo, Felipe García, Stefano Vella, Yves Lévy, Rodolphe Thiébaut, Sheena McCormack

Research output: Contribution to journalComment/debatepeer-review

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.

Original languageEnglish
Pages (from-to)e334-e340
JournalThe Lancet HIV
Volume6
Issue number5
DOIs
Publication statusPublished - May 2019

Keywords

  • HIV
  • randomised controlled trial
  • Multi-arm
  • multi-stage

ASJC Scopus subject areas

  • Epidemiology
  • Immunology
  • Infectious Diseases
  • Virology

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