Open Actively Recruiting

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

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
Male
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

Exclusion Criteria:

Join this Trial

Share:
Study Stats
Protocol No.
24-5230
Category
Healthy Volunteers
Contact
Kevin Pizarro
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06560684
For detailed technical eligibility, visit ClinicalTrials.gov.