drugset / Trial / NCT06087913
Safety and PK Multi-dose Study of TAF/EVG Vaginal Insert
Phase 1
Completed
68 enrolled
Eastern Virginia Medical School
CONRAD · collabCentre for the AIDS Programme of Research in South Africa · collabKenya Medical Research Institute · collabUnited States Agency for International Development (USAID) · collabUniversity of Pittsburgh · collab
RandomizedParallel-groupQuadruple-blindOther
Summary
MATRIX-001 will examine the safety, PK, modeled PD, and acceptability of inserts containing the combination of TAF and EVG applied vaginally, daily for 3 days, then every other day for 14 days. The inserts are ultimately intended to be the basis of an event-driven, on-demand method for prevention of HIV and HSV sexual infection.
Timeline
- Start
- 2023-11-08
- Primary completion
- 2024-12-02
- Completion
- 2024-12-02
Publications
- Background Dobard CW, Peet MM, Nishiura K, Holder A, Dinh C, Mitchell J, Khalil G, Pan Y, Singh ON, McCormick TJ, Agrahari V, Gupta P, Jonnalagadda S, Heneine W, Clark MR, Garcia-Lerma JG, Doncel GF. Single dose topical inserts containing tenofovir alafenamide fumarate and elvitegravir provide pre- and post-exposure protection against vaginal SHIV infection in macaques. EBioMedicine. 2022 Dec;86:104361. doi: 10.1016/j.ebiom.2022.104361. Epub 2022 Nov 21.
- Background Thurman AR, Ouattara LA, Yousefieh N, Anderson PL, Bushman LR, Fang X, Hanif H, Clark M, Singh O, Doncel GF. A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir. Front Cell Infect Microbiol. 2023 Apr 19;13:1130101. doi: 10.3389/fcimb.2023.1130101. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | elvitegravir | Small molecule | 16 mg | Other |
| Subject | tenofovir alafenamide | Small molecule | 20 mg | Other |
Indications
No indication recorded.