drugset / Trial / NCT02431273
Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women
Phase 0
Completed
10 enrolled
Auritec Pharmaceuticals
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabOak Crest Institute of Science · collabThe University of Texas Medical Branch, Galveston · collab
Non-randomizedSingle-groupOpen-labelPrevention
Summary
This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ("Single" IVR); 2) TDF-FTC ("Dual" IVR) and; 3) TDF-FTC-MVC ("Triple" IVR). TDF = tenofovir disoproxil fumarate; FTC = emtrcitabine; MVC = maraviroc
Timeline
- Start
- 2015-06
- Primary completion
- 2016-12
- Completion
- 2016-12
Publications
- Vincent KL, Moss JA, Marzinke MA, Hendrix CW, Anton PA, Pyles RB, Guthrie KM, Dawson L, Olive TJ, Butkyavichene I, Churchman SA, Cortez JM Jr, Fanter R, Gunawardana M, Miller CS, Yang F, Rosen RK, Vargas SE, Baum MM. Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial. PLoS Med. 2018 Sep 28;15(9):e1002655. doi: 10.1371/journal.pmed.1002655. eCollection 2018 Sep.
- Moss JA, Butkyavichene I, Churchman SA, Gunawardana M, Fanter R, Miller CS, Yang F, Easley JT, Marzinke MA, Hendrix CW, Smith TJ, Baum MM. Combination Pod-Intravaginal Ring Delivers Antiretroviral Agents for HIV Prophylaxis: Pharmacokinetic Evaluation in an Ovine Model. Antimicrob Agents Chemother. 2016 May 23;60(6):3759-66. doi: 10.1128/AAC.00391-16. Print 2016 Jun.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Maraviroc | Other / unclassified | — | Other |
| Subject | Tenofovir disoproxil fumarate | Small molecule | — | Other |
| Subject | emtricitabine | Other / unclassified | — | Other |
Indications
No indication recorded.