NCT04686279

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

Safety, PK/PD, Acceptability, and Desirability of a Novel HIV Prevention Douche Among Adolescent Men (DREAM)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Male
• Age: 15 Years – 24 Years
• Healthy volunteers: Accepted

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

Detailed description

On demand and behaviorally-congruent forms of HIV pre-exposure prophylaxis (PrEP) have long been demanded by communities at great risk of HIV, especially men who have sex with men (MSM). The DREAM Program is developing a tenofovir (TFV) douche for on demand PrEP use prior to receptive anal intercourse (RAI), given that the vast majority of MSM very commonly douche prior to RAI (behaviorally-congruent). This ATN protocol seeks to ensure the inclusion of adolescent and young adults' (age 15-24 years) perspectives as next generation biomedical prevention, specifically a rectal douche, is being developed for efficacy. ATN DREAM is an early phase 1, open label study to compare the safety, PK, PD, and acceptability of a TFV-medicated douche. Each participant will undergo a Screening Visit to evaluate eligibility. Baseline Visit will assess pre-dose safety, PK, PD, and behavioral points of reference. Safety, PK, PD, and behavioral readouts are assessed at specified times after the single dose. The TFV douche to be used consists of TFV 660 mg in 125 mL half-normal saline (TFV 5.28 mg/mL). Study objectives including safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of a single TFV douche, are essential to inform the design of an extended safety study of a TFV douche in outpatient pre-RAI contexts. The necessity of extending the testing of new HIV prevention modalities to this proposed adolescent population is motivated by anticipated behavioral differences, not biological ones. Participant accrual will take approximately 9 months and each participant will be on study for approximately 3 months. Total study duration is about 1 year.

Conditions

• HIV/AIDS
• HIV Prevention

Interventions

Type	Name	Description
DRUG	Tenofovir Douche	660 mg TFV in 125 mL hypo-osmolar solution

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2020-12-28
• Last updated: 2023-10-30
• Results posted: 2023-10-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study