Safety, PK, and PD Study of IVRs Releasing TFV and LNG
Status:
Completed
Trial end date:
2018-12-26
Target enrollment:
Participant gender:
Summary
This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG
IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be
used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will
be obtained before, during and after 90 days of continuous or interrupted IVR use.
Phase:
Phase 1
Details
Lead Sponsor:
CONRAD
Collaborators:
Agility Clinical, Inc. United States Agency for International Development (USAID)