Safety, PK, and PD Study of a Vaginal Insert Containing TAF and EVG
Status:
Completed
Trial end date:
2019-03-20
Target enrollment:
Participant gender:
Summary
The purpose of this Phase I study is to assess the safety, pharmacokinetics, and
pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and
elvitegravir (EVG).
This study will be the first-in-human study for a vaginally administered TAF/EVG insert and
will evaluate safety, PK and PD after a single dose. It is hypothesized that the combination
insert will be safe and well-tolerated by study participants and that the insert will offer
an expanded window of preventive activity and a regimen with flexibility and forgiveness.
Phase:
Phase 1
Details
Lead Sponsor:
CONRAD
Collaborators:
Eastern Virginia Medical School United States Agency for International Development (USAID)