NCT02855346

Brief Summary

PK and Safety Study of Vaginal Ring Containing Dapivirine and Levonorgestrel

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

May 3, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2017

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

June 21, 2016

Last Update Submit

May 21, 2018

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Grade 2 or higher Genitourinary adverse event and Grade 3 or higher adverse event as defined by DAIDS

    14 days

Study Arms (2)

200 mg of DPV

EXPERIMENTAL

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

200 mg of DPV + 320 mg LNG

EXPERIMENTAL

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

Interventions

200 mg of DPV + 320 mg LNGCOMBINATION_PRODUCT

DPV VR, containing 200 mg DPV

Also known as: Dapivirine
200 mg of DPV
200 mg of DPVCOMBINATION_PRODUCT

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

Also known as: Dapivirine/Levonorgestrel
200 mg of DPV + 320 mg LNG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women

You may not qualify if:

  • HIV infected women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alabama Hospital

Birmingham, Alabama, 35294, United States

Location

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Friedland BA, Gundacker H, Achilles SL, Chen BA, Hoesley C, Richardson BA, Kelly CW, Piper J, Johnson S, Devlin B, Steytler J, Kleinbeck K, Dangi B, Friend C, Song M, Mensch B, van der Straten A, Jacobson C, Hendrix CW, Brown J, Blithe D, Hiller SL; MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network. Acceptability of a dapivirine levonorgestrel vaginal ring in two Phase 1 trials (MTN-030/IPM 041 and MTN-044/IPM 053/CCN019): Implications for multipurpose prevention technology development. PLoS One. 2025 Jan 14;20(1):e0312957. doi: 10.1371/journal.pone.0312957. eCollection 2025.

    PMID: 39808648DERIVED

MeSH Terms

Interventions

DapivirineLevonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

August 4, 2016

Study Start

May 3, 2017

Primary Completion

August 18, 2017

Study Completion

August 18, 2017

Last Updated

May 22, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)