Tenofovir Douche for HIV/AIDS

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
HIV/AIDS+1 MoreTenofovir Douche - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study 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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Approximately 6 months from the time of enrollment

Month 6
Anatomic distribution of radiolabeled Tenofovir douche
Change in Tenofovir Diphosphate (TFV-DP) concentration

Trial Safety

Safety Progress

1 of 3

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1
Pyridostigmine
2
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Trial Design

1 Treatment Group

Three TFV Medicated Douche Sequences
1 of 1

Experimental Treatment

6 Total Participants · 1 Treatment Group

Primary Treatment: Tenofovir Douche · No Placebo Group · Phase 1

Three TFV Medicated Douche Sequences
Drug
Experimental Group · 1 Intervention: Tenofovir Douche · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir
Not yet FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 6 months from the time of enrollment

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,073 Previous Clinical Trials
31,017,219 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,151 Previous Clinical Trials
4,770,868 Total Patients Enrolled
CONRADOTHER
56 Previous Clinical Trials
11,507 Total Patients Enrolled
Sridhar Nimmagadda, PhDPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are biologically assigned male at birth, 18 years of age or older at screening.
You are willing and able to provide written informed consent to take part in the study.
You are willing to perform simulated RAI with the Coital Dynamic Simulation (CDS) device.
References

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