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

Area of Science:

• Immunology
• Virology
• Clinical Trials

Background:

• Ending the human immunodeficiency virus (HIV) epidemic necessitates novel immune-mediated and nonimmune-mediated prevention strategies.
• Evaluating these interventions demands large, controlled trials to demonstrate efficacy.
• Advances in HIV prevention research highlight the need for updated efficacy trial designs.

Approach:

• This review examines three primary efficacy trial designs: standard of prevention-controlled trials, active-controlled trials, and augmented active-controlled trials.
• Lessons learned from recent trials inform the considerations and success factors for each design.
• Further development and experience are required for the augmented active-controlled trial design.

Key Points:

• Efficacy trials for new HIV prevention interventions are feasible but complex.
• Standard of prevention-controlled trials are suitable for HIV vaccines and monoclonal antibodies.
• Active-controlled designs may be more appropriate for trials of new antiretroviral agents.

Conclusions:

• Careful consideration of trial design is crucial for evaluating new HIV prevention interventions.
• The dynamic nature of HIV prevention research requires adaptable and robust trial methodologies.
• Optimizing trial designs will accelerate the development and implementation of effective HIV prevention strategies.