Clinical Trials

MainTitle

PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel (DAP/LNG)

This study has been completed
Sponsor
International Partnership for Microbicides, Inc.

Collaborator
National Institutes of Health (NIH)

Information provided by (Responsible Party)
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier
NCT02855346

First received: June 21, 2016
Last updated: May 21, 2018
Last Verified: May 2018
History of Changes
Purpose

Purpose

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Condition Intervention Phase
HIV Prevention

Combination Product : 200 mg of DPV + 320 mg LNG
Combination Product : 200 mg of DPV
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel Vaginal Rings

Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures

  • Dapivirine and levonorgestrel concentrations in blood and Vaginal fluid [ Time Frame: 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:
  • Grade 2 or higher Genitourinary adverse event and Grade 3 or higher adverse event as defined by DAIDS [ Time Frame: 14 days ]
    To evaluate the safety of one dapivirine vaginal ring formulation and one dapivirine-levonorgestrel vaginal ring formulations used continuously for 14 days

Enrollment: 24
Study Start Date: May 3, 2017
Study Completion Date: August 18, 2017
Primary Completion Date: August 18, 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 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
Combination Product: 200 mg of DPV + 320 mg LNG

DPV VR, containing 200 mg DPV

Other Name: Dapivirine
Experimental: 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
Combination Product: 200 mg of DPV

DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG

Other Name: Dapivirine/Levonorgestrel

Detailed Description:

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 45 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

  • Healthy women


Exclusion Criteria:
  • HIV infected women

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02855346

Locations

United States, Alabama
University of Alabama Hospital
Birmingham, Alabama, United States, 35294
United States, Pennsylvania
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

International Partnership for Microbicides, Inc.
National Institutes of Health (NIH)
More Information

More Information


Responsible Party: International Partnership for Microbicides, Inc.  
ClinicalTrials.gov Identifier: NCT02855346   History of Changes  
Other Study ID Numbers: MTN-030/IPM 041  
  5UM1 A1068633  
Study First Received: June 21, 2016  
Last Updated: May 21, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Levonorgestrel
Dapivirine

ClinicalTrials.gov processed this data on August 19, 2019
This information is provided by ClinicalTrials.gov.