PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel

Phase 1

Completed

• Conditions: HIV Prevention
• Interventions: Combination Product: 200 mg of DPV; Combination Product: 200 mg of DPV + 320 mg LNG

• Registration Number: NCT02855346
• Lead Sponsor: International Partnership for Microbicides, Inc.

Brief Summary

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Detailed Description

A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel

Study Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Study Start: 2017-05-03
• Primary Completion: 2017-08-18
• Study Completion: 2017-08-18
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-21
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Healthy women

Exclusion Criteria

• HIV infected women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
200 mg of DPV + 320 mg LNG	200 mg of DPV	Each participant will receive a VR containing either 200 mg DPV or 200 mg DPV + 320 mg LNG. Participants will be randomized in a 1:1 ratio. The VR should be worn for approximately 14 consecutive days +/-1 day. The ring will be removed by the participant (or clinician/designee, if necessary) at the Product Use End Visit (PUEV)/Early Termination Visit. The participant will be followed for approximately 2 days following VR removal
200 mg of DPV	200 mg of DPV + 320 mg LNG	Each participant will receive a VR containing either 200 mg DPV or 200 mg DPV + 320 mg LNG. Participants will be randomized in a 1:1 ratio. The VR should be worn for approximately 14 consecutive days +/-1 day. The ring will be removed by the participant (or clinician/designee, if necessary) at the Product Use End Visit (PUEV)/Early Termination Visit. The participant will be followed for approximately 2 days following VR removal

Primary Outcome Measures

Name	Time	Method
Dapivirine and levonorgestrel concentrations in blood and Vaginal fluid	14 days	To characterize the local and systemic pharmacokinetics of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days

Secondary Outcome Measures

Name	Time	Method
Grade 2 or higher Genitourinary adverse event and Grade 3 or higher adverse event as defined by DAIDS	14 days	To evaluate the safety of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days

Trial Locations

Locations (2)

Magee Women's Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Alabama Hospital; 🇺🇸 Birmingham, Alabama, United States