NCT06560684

CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR

A PHASE 2 CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR-BASED PREP EVALUATING EXTENDED SAFETY, ACCEPTABILITY, AND PHARMACOKINETICS/PHARMACODYNAMICS

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product.

Conditions

• Tenofovir

Interventions

Type	Name	Description
DRUG	Oral F/TDF Pills	For 8 weeks of each study period, the participant will take the study product at least weekly prior to anticipated RAI.
DRUG	TFV rectal douche	For 8 weeks of each study period, the participant will take the study product at least weekly prior to anticipated rectal anal intercourse (RAI).

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-05-15
• Completion: 2026-05-15
• First posted: 2024-08-19
• Last updated: 2026-01-16

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study