Trial design for next generation PrEP

HIV Forum

The extremely high efficacy of current PrEP raises new challenges for next-generation PrEP.

Placebo-controlled studies are seen as unethical, now that oral PrEP should be standard of care prevention. It is also impractical to use randomised studies with active controls: whether for non-inferiority or superiority endpoints, the studies would need to be too large.

This satellite session organised by the HIV Forum discussed new approaches that are already being used in phase 3 PrEP studies using longer-acting drugs like islatravir and lenacapavir. The webcast is now online.

Reference

Innovative clinical trial designs to accelerate increase in PrEP choices. IAS 2021 satellite session. 18 July 2021.
https://forumresearch.org/hiv-forum/prep-project/meetings