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Antiretroviral

Rectal vs Oral Tenofovir for HIV Prevention

Phase 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older at the time of screening informed consent
Assigned male at birth
Must not have
At screening, participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection
History of significant gastrointestinal bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 through 19
Awards & highlights
No Placebo-Only Group

Summary

This trial is a Phase 2 study that will be conducted at multiple locations. It will involve two periods where participants will be randomly assigned to one of two sequences of products to be used on an on

Who is the study for?
This trial is for individuals willing to compare two forms of a drug called Tenofovir: one taken by mouth and the other used as a rectal douche. Participants will try both methods in different sequences with a break in between. The study aims to assess safety, how well people like the method, if they stick with it, and how the body processes the drug.
What is being tested?
The study is testing oral F/TDF pills against TFV rectal douches in an on-demand fashion over two periods. Each participant will use both formulations for 8 weeks each, separated by a short break. Researchers want to see which form is safer, more acceptable and effective based on adherence rates and drug levels in the body.
What are the potential side effects?
Possible side effects are not detailed here but may include gastrointestinal discomfort from either formulation or irritation from the rectal douche. Side effects related to Tenofovir typically can include nausea, vomiting, diarrhea, dizziness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I was assigned male at birth.
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I have had radioactive iodine treatment at least 5 times, including once in the last 3 months.
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I have used an enema or rectal douche frequently before sex in the past year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have symptoms or a diagnosis of an infection in my rectal or reproductive area, or a urinary tract infection.
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I have had serious bleeding in my stomach or intestines.
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I have been using or plan to use HIV prevention medication recently and during the study.
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I am showing signs that might indicate a recent HIV infection.
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My kidney function is good, and I have no major lab test issues.
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I have a serious heart rhythm problem or kidney disease.
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I have had a serious heart or lung problem recently.
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I have an active hepatitis B infection.
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My blood clotting test shows a level 2 or higher issue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 through 19
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 through 19 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade 2 or higher adverse events during each study Period
Self-report on ease of use, product liking, and likelihood of future use during each study Period
Secondary study objectives
TFV and FTC concentrations in blood plasma and rectal tissue biopsies
TFV-DP and FTC-TP concentrations in PBMCs, rectal tissue biopsies, and mucosal mononuclear cells (MMC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group BExperimental Treatment2 Interventions
Those participants assigned to Group B will start with the on-demand oral F/TDF 200 mg/300 mg sequence for 8 weeks and then after a 2-4 week washout will switch to the rectal TFV 660 mg douche for the next 8 weeks (Period 2).
Group II: Group AExperimental Treatment2 Interventions
Those participants assigned to Group A will start with the rectal TFV 660 mg douche for the first 8 weeks (Period 1) and then after a 2-4 week washout will switch to the on-demand oral F/TDF 200 mg/300 mg sequence for the next 8 weeks (Period 2).

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,312 Previous Clinical Trials
5,546,566 Total Patients Enrolled
~100 spots leftby Jan 2026
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