Rectal Insert Safety Study

(RITE PrEP Trial)

Overseen By Karen Dominguez, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eastern Virginia Medical School

Must not be taking: NSAIDs, Anticoagulants, Immunomodulators, others

Disqualifiers: Hepatitis, Kidney disease, Bowel disease, others

Compensation: Varies

Number of Visits: 7

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Cassie Grimsley Ackerley, MD, MSc

Principal Investigator

Emory School of Medicine

Richard E Haaland

Principal Investigator

Centers for Disease Control and Prevention

Gustavo F Doncel, MD, PhD

Principal Investigator

CONRAD

Eligibility Criteria

The RITE PrEP study is for individuals aged 18-59 who have a history of receptive anal intercourse, are HIV-negative, and can give informed consent. They must be willing to undergo various tests including blood, urine, and rectal biopsies. Women must agree to additional cervicovaginal secretion collection. Participants should not have bowel conditions that could worsen with the study or distort anatomy.

Inclusion Criteria

I am willing to provide blood, urine, rectal secretion samples, and undergo a rectal biopsy.

I have had receptive anal intercourse in my life.

I am cleared for a rectal biopsy.

Exclusion Criteria

Significant laboratory abnormalities at baseline including but not limited to hemoglobin ≤ 10 g/dL, platelet count <100,000, Aspartate aminotransferase (AST) or alanine transaminase (ALT) >1.3x ULN, serum creatinine >1.3x upper limit of normal (ULN), PTT > 1.5x ULN or International normalized ratio (INR) >1.5x ULN

I have kidney disease or my kidney function is low.

I have a history of serious lower GI tract conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants self-administer two TAF/EVG or placebo rectal inserts for 3 consecutive days

1 week

3 visits (in-person) at 24, 48, and 72 hours after last dose

Washout

A washout period between study phases

1-4 weeks

Phase 2 Treatment

Participants administer two TAF/EVG or placebo rectal inserts every other day for 7 doses

2 weeks

4 visits (in-person) at 24, 48, 72 hours, and 7 days after final dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TAF/EVG

Trial Overview This trial is testing the safety and how the body processes TAF/EVG rectal inserts compared to placebo inserts over several days. It's double-blind (neither researchers nor participants know who gets what), randomized (assigned by chance), and involves two phases with different dosing schedules.

Participant Groups

Group I: Active Experimental Treatment 1 Intervention

2 TAF/EVG (20/16mg) rectal inserts

Group II: Placebo Placebo Group 1 Intervention

2 Matching placebo inserts

Who Is Running the Clinical Trial?

Eastern Virginia Medical School

Lead Sponsor

Trials

77

Recruited

16,500+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

CONRAD

Collaborator

Trials

60

Recruited

11,800+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+