drugset
drugset / Trial / NCT06560684

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

NCT06560684 ↗

Phase 2 Completed 150 enrolled National Institute of Allergy and Infectious Diseases (NIAID)
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2024-10-29
Primary completion
2026-06-16
Completion
2026-06-16

Drugs

EvaluationDrugModalityDoseRoute
Subject F/TDF Unknown 200 mg Oral
Subject F/TDF Unknown 300 mg Oral
Subject Tenofovir Small molecule 660 mg Other

Indications

No indication recorded.