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

International Partnership for Microbicides (IPM) logo

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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