Control groups for HIV prevention efficacy trials: what does the future hold?
Journal
Current opinion in HIV and AIDS
ISSN: 1746-6318
Titre abrégé: Curr Opin HIV AIDS
Pays: United States
ID NLM: 101264945
Informations de publication
Date de publication:
01 11 2023
01 11 2023
Historique:
pmc-release:
01
11
2024
medline:
23
10
2023
pubmed:
15
9
2023
entrez:
15
9
2023
Statut:
ppublish
Résumé
Ending the HIV epidemic will require the development of additional effective immune-mediated and nonimmune-mediated means of HIV prevention. Evaluating novel interventions requires large, controlled trials demonstrating efficacy. Recent advances in the field of HIV prevention necessitate new approaches to efficacy trial design. Three classes of efficacy trial designs are possible: standard of prevention-controlled trials, active-controlled trials, and active-controlled trials augmented with external control data. Recent experience with these approaches provides lessons on considerations around and success of the designs. Additional experience and development is needed for the augmented active-controlled trial design. Efficacy trials of new HIV prevention interventions are feasible but require careful consideration, given the complexity and dynamic state of the prevention field. While standard of prevention-controlled efficacy trials are reasonable approaches for HIV vaccine and monoclonal antibody efficacy trials, trials of new antiretroviral agents may require active-controlled designs.
Identifiants
pubmed: 37712852
doi: 10.1097/COH.0000000000000818
pii: 01222929-990000000-00063
pmc: PMC10575689
mid: NIHMS1927447
doi:
Substances chimiques
Anti-Retroviral Agents
0
AIDS Vaccines
0
Types de publication
Review
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
349-356Subventions
Organisme : NIAID NIH HHS
ID : UM1 AI069496
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068635
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA152089
Pays : United States
Organisme : NIAID NIH HHS
ID : R56 AI143418
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI068614
Pays : United States
Informations de copyright
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
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