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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02855346
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Study Description
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Brief Summary:
PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Condition or disease Intervention/treatment Phase
HIV Prevention Combination Product: 200 mg of DPV + 320 mg LNG Combination Product: 200 mg of DPV Phase 1

Detailed Description:
A Phase 1, Randomized, Double-Blind Pharmacokinetic and Safety Study of Dapivirine/Levonorgestrel
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Actual Study Start Date : May 3, 2017
Actual Primary Completion Date : August 18, 2017
Actual Study Completion Date : August 18, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women

Exclusion Criteria:

  • HIV infected women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855346


Locations
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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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT02855346    
Other Study ID Numbers: MTN-030/IPM 041
5UM1 A1068633 ( Other Grant/Funding Number: Division of AIDS, US National Institute of Allergy and Infectious Diseases US Eunice Kennedy Shriver National Institute )
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dapivirine
Levonorgestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
 Contraceptives, Oral, Synthetic
Contraceptives, Oral
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents