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Multi-arm, multi-stage randomised controlled trials for evaluating therapeutic HIV cure interventions
- Source :
- The Lancet HIV, The Lancet HIV, 2019, 6 (5), pp.e334-e340. ⟨10.1016/s2352-3018(19)30082-7⟩, Lancet HIV, Lancet HIV, Elsevier, 2019, 6 (5), pp.e334-e340. ⟨10.1016/S2352-3018(19)30082-7⟩
- Publication Year :
- 2019
- Publisher :
- HAL CCSD, 2019.
-
Abstract
- International audience; 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.
- Subjects :
- 0301 basic medicine
medicine.medical_specialty
Epidemiology
[SDV]Life Sciences [q-bio]
Immunology
Human immunodeficiency virus (HIV)
Psychological intervention
HIV Infections
Context (language use)
Placebo
medicine.disease_cause
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases
Antiretroviral Therapy, Highly Active
Virology
Humans
Multicenter Studies as Topic
Medicine
030212 general & internal medicine
Intensive care medicine
Randomized Controlled Trials as Topic
business.industry
[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy
030112 virology
3. Good health
Clinical trial
Multi stage
Treatment Outcome
Infectious Diseases
Anti-Retroviral Agents
Research Design
HIV-1
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
business
Viral load
Subjects
Details
- Language :
- English
- ISSN :
- 23523018 and 24054704
- Database :
- OpenAIRE
- Journal :
- The Lancet HIV, The Lancet HIV, 2019, 6 (5), pp.e334-e340. ⟨10.1016/s2352-3018(19)30082-7⟩, Lancet HIV, Lancet HIV, Elsevier, 2019, 6 (5), pp.e334-e340. ⟨10.1016/S2352-3018(19)30082-7⟩
- Accession number :
- edsair.doi.dedup.....966401564b57485727bbd8d7e40ee017