Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study — RITE PrEP  

Safety Issues Clinical Trial

Official title: A Double-Blind, Placebo-Controlled, Randomized Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Rectally Administered Tenofovir Alafenamide/Elvitegravir Inserts

Status Recruiting

Clinical Trial Summary

This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.

Clinical Trial Description

The purpose of this study is to collect data regarding the safety and pharmacokinetics of repeat dosing schedules of TAF and EVG administered rectally to inform the development of future studies to assess the efficacy of this drug combination and mode of administration for use as on-demand PrEP in individuals at risk of acquiring HIV-1 infection.

Eligible participants will be stratified according to sex assigned at birth and then randomized 1:1 to either receive TAF/EVG inserts or placebo for self-administration during the study phases. During Phase 1, participants will self-administer two TAF/EVG or placebo rectal inserts for 3 consecutive days and return to the clinic at 24, 48, and 72 hours after the last dose for biological sample collection. During Phase 2, participants will administer two TAF/EVG or placebo rectal inserts every other day for 7 doses and return to the clinic at 24 hours, 48 hours, 72 hours and 7 days after the final dose for biological sample collection. There will be a washout period of 7 to 28 days between the study phases. ;

Related Conditions & MeSH terms

• Safety Issues

• NCT number: NCT06274398
• Study type: Interventional
• Source: Eastern Virginia Medical School
• Contact: Karen Dominguez, MPH
• Phone: 757-446-5994
• Email: domingk@evms.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: January 16, 2024
• Completion date: December 31, 2024