drugset / Trial / NCT03234400
A Phase 1, Randomized Pharmacokinetics and Safety Study of Extended Duration Dapivirine Vaginal Rings
Phase 1
Completed
49 enrolled
International Partnership for Microbicides, Inc.
National Institute of Allergy and Infectious Diseases (NIAID) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Participants will be randomized to one of three study vaginal rings (VRs) in a 1:1:1 ratio, 25 mg, 100 mg or 200 mg VRs.
Timeline
- Start
- 2017-12-04
- Primary completion
- 2018-10-23
- Completion
- 2019-01-23
Publications
- Hawley I, Song M, Scheckter R, McClure T, Piper J, Chen BA, Hoesley C, Liu AY, van der Straten A. Users' Preferred Characteristics of Vaginal Rings for HIV Prevention: A Qualitative Analysis of Two Phase I Trials. AIDS Res Hum Retroviruses. 2022 Apr;38(4):313-326. doi: 10.1089/AID.2021.0077. Epub 2022 Feb 11.
- Liu AY, Dominguez Islas C, Gundacker H, Neradilek B, Hoesley C, van der Straten A, Hendrix CW, Beamer M, Jacobson CE, McClure T, Harrell T, Bunge K, Devlin B, Nuttall J, Spence P, Steytler J, Piper JM, Marzinke MA; MTN-036/IPM 047 Protocol Team for the Microbicide Trials Network. Phase 1 pharmacokinetics and safety study of extended duration dapivirine vaginal rings in the United States. J Int AIDS Soc. 2021 Jun;24(6):e25747. doi: 10.1002/jia2.25747.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dapivirine | Small molecule | 25 mg | Other |
| Subject | dapivirine | Small molecule | 100 mg | Other |
| Subject | dapivirine | Small molecule | 200 mg | Other |