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Antiviral

Tenofovir Douche for HIV/AIDS (DREAM-02 Trial)

Phase 1
Waitlist Available
Led By Sridhar Nimmagadda, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 months from the time of enrollment
Awards & highlights

DREAM-02 Trial Summary

This trial is testing different ways of using a rectal douche before and after simulated receptive anal intercourse, to see how well it protects against HIV acquisition.

Eligible Conditions
  • HIV/AIDS
  • HIV Prevention

DREAM-02 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months from the time of enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months from the time of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Tenofovir Diphosphate (TFV-DP) concentration
Secondary outcome measures
Anatomic distribution of radiolabeled Tenofovir douche

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

DREAM-02 Trial Design

1Treatment groups
Experimental Treatment
Group I: Three TFV Medicated Douche SequencesExperimental Treatment1 Intervention
Once enrolled, participants will complete a baseline sampling session and then three sequences of study product administration, along with sRAI and administration of autologous seminal fluid. Sequence A will be 1 TFV douche followed by sRAI; Sequence B will be one dose of TFV douche followed sRAI then a tap water douche; Sequence C will be 1 tap water douche followed sRAI then by a single dose of TFV douche. There will be a washout period of at least 14 days between sequences. Participants will have sequences administered in clinic or a research unit, followed by imaging and various specimen collections over 8 hours.
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?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,463 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,774 Total Patients Enrolled
CONRADOTHER
58 Previous Clinical Trials
11,607 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Tenofovir Douche been employed in other medical experiments before?

"Presently, 15 clinical trials are studying Tenofovir Douche. Of these investigations, 6 have entered Phase 3 while the remainder remain in earlier stages of study. The majority of research sites for this medication can be found around Wonju, Kangwon-do; however there are 70 other locations conducting studies relating to Tenofovir Douche as well."

Answered by AI

Has the Federal Drug Administration given its official endorsement to Tenofovir Douche?

"The safety of Tenofovir Douche has been given a score of 1 due to limited clinical evidence from Phase 1 trials, indicating that its efficacy and safety are yet to be established."

Answered by AI

Are individuals still able to participate in this clinical experiment?

"Affirmative. As indicated by the clinicaltrials.gov website, this research project is currently recruiting participants. It was first posted on June 1st 2021 and most recently updated on October 14th 2022; 16 people are needed to be recruited from a single medical site."

Answered by AI

Is this the inaugural trial for this particular research protocol?

"Presently, Tenofovir Douche is the topic of 15 ongoing clinical trials that span 10 countries and 17 cities. The initial trial first began in 2011 as a Phase 1 experiment sponsored by Bristol-Myers Squibb with 32 participants. Since then, 102 subsequent studies have been finished."

Answered by AI

How many enrollees have participated in this research endeavor?

"Correct. According to clinicaltrials.gov, the trial which was first published on June 1st 2021 is actively recruiting patients and has recently been updated on October 14th 2022. There are 16 participants sought from a single medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse
2021. "Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04195776.
~2 spots leftby Apr 2025
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