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

International Partnership for Microbicides (IPM)

Status and phase: Completed; Phase 1

Conditions: HIV Prevention

Treatments: Combination Product: 200 mg of DPV; Combination Product: 200 mg of DPV + 320 mg LNG

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02855346

MTN-030/IPM 041

5UM1 A1068633 (Other Grant/Funding Number)

Details and patient eligibility

About

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Full description

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

Enrollment: 24 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy women

Exclusion criteria

• HIV infected women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

200 mg of DPV

Experimental group

Description:

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

Treatment:

Combination Product: 200 mg of DPV + 320 mg LNG

200 mg of DPV + 320 mg LNG

Experimental group

Description:

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

Treatment:

Combination Product: 200 mg of DPV