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Antiviral

Tenofovir Douche for HIV/AIDS

Phase 1
Waitlist Available
Led By Craig W Hendrix, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 hour, 24 hours, or 72 hours after the tfv douche administration
Awards & highlights

Study Summary

This trial is testing a one-time dose of a medicated douche to see if it is safe and effective in preventing HIV acquisition. The goal is to use this information to design a study of extended use of the douche.

Eligible Conditions
  • HIV/AIDS
  • HIV Prevention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 hour, 24 hours, or 72 hours after the tfv douche administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 hour, 24 hours, or 72 hours after the tfv douche administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of TFV Douche as Assessed by Product Acceptability Questionnaire
Safety of TFV Douche as Assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events
Tenofovir Diphosphate (TFV-DP) Concentration

Side effects data

From 2022 Phase 1 trial • 8 Patients • NCT04686279
25%
Type I Diabetes
13%
Nausea
13%
Polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
TFV Medicated Douche

Trial Design

1Treatment groups
Experimental Treatment
Group I: TFV Medicated DoucheExperimental Treatment1 Intervention
Once enrolled, participants will complete a baseline sampling session and then a single dose of study product administration. Post-dose observations and data collection will follow at 1, 6, 24, and 72 hours, using a sparse PK sampling design in which plasma and peripheral blood mononuclear cells (PBMC) are collected at each designated time. Between sampling windows, YMSM will complete a web-survey examining their perceived reactions and comfort using the study douche, factors influencing product use in the future, and comfort with the trial procedures. The survey will be administered after dosing but scheduled not to interfere with other study assessments. Sampling for safety, PK, PD, and acceptability assessments will be collected according to the schedule of events. Phase I Trial participants will complete an in-depth interview as part of their Termination visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir Douche
2021
Completed Phase 1
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,999 Previous Clinical Trials
42,879,434 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,502 Previous Clinical Trials
4,186,734 Total Patients Enrolled
Emory UniversityOTHER
1,636 Previous Clinical Trials
2,560,565 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)
2021. "Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04686279.
~2 spots leftby Apr 2025
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