NCT06274398

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	TAF/EVG rectal insert	Phase 1: rectal inserts applied daily for 3 consecutive days Phase 2: rectal inserts applied every other day for 14 days
DRUG	Matching placebo rectal insert	Phase 1: rectal inserts applied daily for 3 consecutive days Phase 2: rectal inserts applied every other day for 14 days

Timeline

• Start date: 2024-01-16
• Primary completion: 2025-03-31
• Completion: 2025-05-16
• First posted: 2024-02-23
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study