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Antiretroviral

Group A for Tenofovir

Phase 2
Waitlist Available
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
1. Assigned male at birth
2.18 years of age or older at the time of screening informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 through 19
Awards & highlights

Summary

This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product.

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

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
Any adverse event leading to study product discontinuation during each study Period
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
Percent prescribed weekly doses taken in each Period using multiple subjective and objective measures
Proportion of participants who reported being most likely to use the TFV douche in the future (following Period 2)
TFV and FTC concentrations in blood plasma and rectal tissue biopsies
+1 more

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).

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Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,289 Previous Clinical Trials
5,499,649 Total Patients Enrolled
~100 spots leftby Jan 2026
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