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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%
Polyp
13%
Nausea
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

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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
3,278 Previous Clinical Trials
5,487,701 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,275 Previous Clinical Trials
14,840,632 Total Patients Enrolled
CONRADOTHER
58 Previous Clinical Trials
11,607 Total Patients Enrolled
~1 spots leftby Jun 2025
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