PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel

HIV Prevention Clinical Trial

— DAP/LNG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02855346
• Other study ID #: MTN-030/IPM 041
• Secondary ID: 5UM1 A1068633
• Status: Completed
• Phase: Phase 1
• Start date: May 3, 2017
• Est. completion date: August 18, 2017

Study information

• Verified date: May 2018
• Source: International Partnership for Microbicides, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 18, 2017
• Est. primary completion date: August 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy women

Exclusion Criteria:

• HIV infected women

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Combination Product:
• 200 mg of DPV + 320 mg LNG
DPV VR, containing 200 mg DPV
• 200 mg of DPV
DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG

Locations

Country	Name	City	State
United States	University of Alabama Hospital	Birmingham	Alabama
United States	Magee Women's Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
International Partnership for Microbicides, Inc.	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dapivirine and levonorgestrel concentrations in blood and Vaginal fluid	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	14 days
Secondary	Grade 2 or higher Genitourinary adverse event and Grade 3 or higher adverse event as defined by DAIDS	To evaluate the safety of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days	14 days