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Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM)

NCT04686279 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-10-30

Study results available
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Summary

ATN DREAM is an early phase-1, open label study to examine the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a one-dose tenofovir (TFV) medicated douche. 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

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Craig W Hendrix, MD · Johns Hopkins University

  • Renata Arrington-Sanders, MD · Johns Hopkins University

  • Allison L Agwu, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-11-30
Completion
2022-11-30
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 NCT04686279 on ClinicalTrials.gov