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Tenofovir Rectal Douche to Prevent HIV Transmission

NCT04016233 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-06-09

No results posted yet for this study

Summary

DREAM-03 is an early phase-1, open label study to compare the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of 3 sequences of tenofovir (TFV) and non-medicated douches. The overall goal is to inform the design of an extended safety study of an on-demand and behaviorally congruent TFV douche to confer protection from HIV acquisition in an outpatient pre-RAI context.

Conditions

Interventions

DRUG

Tenofovir douche

660 mg TFV in 125 mL hypo-osmolar solution

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Pittsburgh

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Craig Hendrix, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2021-04-27
Completion
2021-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04016233 on ClinicalTrials.gov