PK and Safety Study of Vaginal Rings Containing Dapivirine and Levonorgestrel

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

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

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

Conditions
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HIV Prevention

Intervention / Treatment
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* Combination Product: 200 mg of DPV + 320 mg LNG
* Combination Product: 200 mg of DPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women Exclusion Criteria: HIV infected women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg of DPV<br>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<br>* DPV VR, containing 200 mg DPV<br>* Other names: Dapivirine;|
| Experimental: 200 mg of DPV + 320 mg LNG<br>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<br>* DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG<br>* Other names: Dapivirine/Levonorgestrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |