Control groups for HIV prevention efficacy trials: what does the future hold?

Curr Opin HIV AIDS. 2023 Nov 1;18(6):349-356. doi: 10.1097/COH.0000000000000818. Epub 2023 Sep 11.

Abstract

Purpose of review: 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.

Recent findings: 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.

Summary: 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.

Publication types

  • Review
  • Research Support, N.I.H., Extramural

MeSH terms

  • AIDS Vaccines*
  • Anti-Retroviral Agents / therapeutic use
  • Control Groups
  • HIV Infections* / drug therapy
  • Humans
  • Randomized Controlled Trials as Topic
  • Research Design

Substances

  • Anti-Retroviral Agents
  • AIDS Vaccines