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

NCT06274398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-07-25

No results posted yet for this study

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.

Conditions

  • Safety Issues

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Cassie Grimsley Ackerley, MD, MSc · Emory School of Medicine

  • Richard E Haaland · Centers for Disease Control and Prevention

  • Gustavo F Doncel, MD, PhD · CONRAD

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2025-03-31
Completion
2025-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274398 on ClinicalTrials.gov