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First received: August 02, 2024

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

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Tenofovir

Study Type: INTERVENTIONAL


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

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.

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