CONRAD A15-138/ ENRICH

Status:Completed
Phase:I
Principal Investigator(s):
Objective:First-in-woman study to evaluate the TFV/LNG or placebo IVR over the full 3 months duration using the IVRs in either a continuous or interrupted use regimen (4 treatment/dosing arms). The objectives of the study were to describe the safety (primary objective), acceptability and PK (secondary objectives) and PD (exploratory objective) of the TFV/LNG IVR versus the placebo IVR, over the full 90 days. Results summary: The TFV/LNG IVR was safe and well tolerated, and met PK/PD pre-specified levels, compatible with HIV, HSV and contraceptive activity. This IVR is capable of releasing in a controlled manner two very different drugs in amounts that differ by roughly 500-fold. Drug release from the IVRs achieved high local concentrations and low plasma levels, minimizing potential systemic AEs. Maintaining high local concentrations post IVR removal (dosing forgiveness) and multipurpose prevention of STIs and pregnancy are value-added features of this unique IVR. Our data currently would support a preferred recommendation of continuous IVR use, as this regimen shows a more consistent PK/PD pattern. Last updated October 18, 2022
Prevention Option(s):Microbicides, MPTs
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionContinuous TFV/LNG IVR
Mode of DeliveryRing
ARMsExperimental
DescriptionInterrupted TFV/LNG IVR
Mode of DeliveryRing
ARMsExperimental
Results: Randomized, placebo controlled phase I trial of the safety, pharmacokinetics, pharmacodynamics and acceptability of a 90 day tenofovir plus levonorgestrel vaginal ring used continuously or cyclically
Official Code: NCT03279120
Trial Sponsors: CONRAD
Start Date
End Date
September 5, 2017
December 26, 2018
Enrollment:47
Age range: 18 Years ↔ 50
Population:Cisgender Men