A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention.

Sharon A RiddlerClifton W KellyCraig J HoesleyKen S HoJeanna M PiperStacey EdickFaye HeardGustavo F DoncelSherri JohnsonPeter L AndersonRhonda M BrandRatiya Pamela Kunjara Na AyudhyaJosé A BauermeisterSharon L HillierCraig W Hendrix

Published in: The Journal of infectious diseases (2024)

Rectal administration of TAF/EVG inserts achieved high rectal tissue concentrations of EVG and TFV-DP with low systemic drug exposure and demonstrable ex vivo inhibition of HIV infection for 72 hours.

Keyphrases

clinical trial
antiretroviral therapy
rectal cancer
phase ii
study protocol
open label
drug induced