PK and Safety Study of Vaginal Rings Containing Dapivirin... | NCT02855346

NCT02855346

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
5UM1 A1068633	Other Grant/Funding Number	Division of AIDS, US National Institute of Allergy and Infectious Diseases US Eunice Kennedy Shriver National Institute

Status Module

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
200 mg of DPV + 320 mg LNG	Combination Product	DPV VR, containing 200 mg DPV	200 mg of DPV

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama Hospital		Birmingham	Alabama	35294	United States
Magee Women's Hospital of UPMC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39808648	Derived	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.

IPD Sharing Statement Module

Intervention Browse Module

ID	Term
C481671	Dapivirine
D016912	Levonorgestrel