drugset

drugset / Trial / NCT04047420

Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally

NCT04047420 ↗

Phase 1 Completed 23 enrolled National Institute of Allergy and Infectious Diseases (NIAID) CONRAD · collab

NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals.

Timeline

Start: 2019-12-11
Primary completion: 2021-03-03
Completion: 2021-04-07

Publications

Riddler SA, Kelly CW, Hoesley CJ, Ho KS, Piper JM, Edick S, Heard F, Doncel GF, Johnson S, Anderson PL, Brand RM, Kunjara Na Ayudhya RP, Bauermeister JA, Hillier SL, Hendrix CW. A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention. J Infect Dis. 2024 Sep 23;230(3):696-705. doi: 10.1093/infdis/jiae211.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	elvitegravir	Small molecule	16 mg	Rectal
Subject	tenofovir alafenamide	Small molecule	20 mg	Rectal

Indications