Trial Outcomes & Findings for Tenofovir Rectal Douche to Prevent HIV Transmission Among Adolescents (ATN DREAM) (NCT NCT04686279)

Last Updated: 2023-10-30

Results Overview

Colonic tissue cell TFV-DP concentrations (femtomoles/million cells) will be measured the study douche administration, based on the individual participant's sampling schedule, on Day 1 (at 1 hour post dose), Day 2 (24 hours post dose), or Day 4 (72 hours post dose).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

8 participants

Primary outcome timeframe

At 1 hour, 24 hours, or 72 hours after the TFV douche administration

Results posted on

2023-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	TFV Medicated Douche Once enrolled, participants will complete a baseline sampling session and then a single dose of study product administration. Post-dose observations and data collection will follow at 1, 24, or 72 hours, using a sparse PK sampling design in which plasma and peripheral blood mononuclear cells (PBMC) are collected at each designated time. Between sampling windows, YMSM will complete a web-survey examining their perceived reactions and comfort using the study douche, factors influencing product use in the future, and comfort with the trial procedures. The survey will be administered after dosing but scheduled not to interfere with other study assessments. Sampling for safety, PK, PD, and acceptability assessments will be collected according to the schedule of events. Phase I Trial participants will complete an in-depth interview as part of their Termination visit. Tenofovir Douche: 660 mg TFV in 125 mL hypo-osmolar solution
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TFV Medicated Douche n=8 Participants Once enrolled, participants will complete a baseline sampling session and then a single dose of study product administration. Post-dose observations and data collection will follow at 1, 6, 24, and 72 hours, using a sparse PK sampling design in which plasma and peripheral blood mononuclear cells (PBMC) are collected at each designated time. Between sampling windows, YMSM will complete a web-survey examining their perceived reactions and comfort using the study douche, factors influencing product use in the future, and comfort with the trial procedures. The survey will be administered after dosing but scheduled not to interfere with other study assessments. Sampling for safety, PK, PD, and acceptability assessments will be collected according to the schedule of events. Phase I Trial participants will complete an in-depth interview as part of their Termination visit. Tenofovir Douche: 660 mg TFV in 125 mL hypo-osmolar solution
Age, Continuous	21 Years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Body Mass Index	27.0 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: At 1 hour, 24 hours, or 72 hours after the TFV douche administration

Population: Participants assigned to each sampling schedule (1 hr, 24hr, 72 hr) are included below.

Outcome measures

Outcome measures
Measure	TFV Medicated Douche n=8 Participants Once enrolled, participants will complete a baseline sampling session and then a single dose of study product administration. Post-dose observations and data collection will follow at 1, 24, and 72 hours, using a sparse PK sampling design in which plasma and peripheral blood mononuclear cells (PBMC) are collected at each designated time. Between sampling windows, YMSM will complete a web-survey examining their perceived reactions and comfort using the study douche, factors influencing product use in the future, and comfort with the trial procedures. The survey will be administered after dosing but scheduled not to interfere with other study assessments. Sampling for safety, PK, PD, and acceptability assessments will be collected according to the schedule of events. Phase I Trial participants will complete an in-depth interview as part of their Termination visit. Tenofovir Douche: 660 mg TFV in 125 mL hypo-osmolar solution
Tenofovir Diphosphate (TFV-DP) Concentration 1 hour post-dose	2441 femtomole/million cells Interval 1033.0 to 5108.0
Tenofovir Diphosphate (TFV-DP) Concentration 24 hours post-dose	3472 femtomole/million cells Interval 772.0 to 9460.0
Tenofovir Diphosphate (TFV-DP) Concentration 72 Hours post-dose	406 femtomole/million cells Interval 406.0 to 406.0

PRIMARY outcome

Timeframe: Following administration of study product, up to 1 hour

Using a 4-point scale (1=Completely Unacceptable; 2=Somewhat Unacceptable; 3=Somewhat Acceptable; 4=Highly Acceptable), participants were asked to answer the following question about their experience with the product: "If a rectal douche like the one you were administered today at the clinic could protect you against HIV, would you consider using this douche?". The endpoint was operationalized as binary, with scores 1 to 2 grouped as "low acceptability" and scores 3 to 4 as "high acceptability".

Outcome measures

Outcome measures
Measure	TFV Medicated Douche n=8 Participants Once enrolled, participants will complete a baseline sampling session and then a single dose of study product administration. Post-dose observations and data collection will follow at 1, 24, and 72 hours, using a sparse PK sampling design in which plasma and peripheral blood mononuclear cells (PBMC) are collected at each designated time. Between sampling windows, YMSM will complete a web-survey examining their perceived reactions and comfort using the study douche, factors influencing product use in the future, and comfort with the trial procedures. The survey will be administered after dosing but scheduled not to interfere with other study assessments. Sampling for safety, PK, PD, and acceptability assessments will be collected according to the schedule of events. Phase I Trial participants will complete an in-depth interview as part of their Termination visit. Tenofovir Douche: 660 mg TFV in 125 mL hypo-osmolar solution
Acceptability of TFV Douche as Assessed by Product Acceptability Questionnaire Low Acceptability	0 Participants
Acceptability of TFV Douche as Assessed by Product Acceptability Questionnaire High Acceptability	8 Participants

PRIMARY outcome

Timeframe: Following administration of study product, up to 7 days

The safety of a single dose of a TFV douche when applied rectally is measured by the number of ≥Grade 2 adverse events (AEs) as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, and whether AEs are attributed to the study product.

Outcome measures

Outcome measures
Measure	TFV Medicated Douche n=8 Participants Once enrolled, participants will complete a baseline sampling session and then a single dose of study product administration. Post-dose observations and data collection will follow at 1, 24, and 72 hours, using a sparse PK sampling design in which plasma and peripheral blood mononuclear cells (PBMC) are collected at each designated time. Between sampling windows, YMSM will complete a web-survey examining their perceived reactions and comfort using the study douche, factors influencing product use in the future, and comfort with the trial procedures. The survey will be administered after dosing but scheduled not to interfere with other study assessments. Sampling for safety, PK, PD, and acceptability assessments will be collected according to the schedule of events. Phase I Trial participants will complete an in-depth interview as part of their Termination visit. Tenofovir Douche: 660 mg TFV in 125 mL hypo-osmolar solution
Safety of TFV Douche as Assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Number of Grade 2 Adverse Events	3 events
Safety of TFV Douche as Assessed by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Number of Grade 2 AEs attributed to study product	0 events

Adverse Events

TFV Medicated Douche

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TFV Medicated Douche n=8 participants at risk Once enrolled, participants will complete a baseline sampling session and then a single dose of study product administration. Post-dose observations and data collection will follow at 1, 6, 24, and 72 hours, using a sparse PK sampling design in which plasma and peripheral blood mononuclear cells (PBMC) are collected at each designated time. Between sampling windows, YMSM will complete a web-survey examining their perceived reactions and comfort using the study douche, factors influencing product use in the future, and comfort with the trial procedures. The survey will be administered after dosing but scheduled not to interfere with other study assessments. Sampling for safety, PK, PD, and acceptability assessments will be collected according to the schedule of events. Phase I Trial participants will complete an in-depth interview as part of their Termination visit. Tenofovir Douche: 660 mg TFV in 125 mL hypo-osmolar solution
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • Adverse events were collected for the duration of the trial (3 months)
Metabolism and nutrition disorders Type I Diabetes	25.0% 2/8 • Number of events 3 • Adverse events were collected for the duration of the trial (3 months)
Gastrointestinal disorders Polyp	12.5% 1/8 • Number of events 1 • Adverse events were collected for the duration of the trial (3 months)

Additional Information

Dr. Craig Hendrix

Johns Hopkins University

Phone: 410-955-9707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place