NCT03255915

PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)

Randomized Order, Controlled, Double Blind, Crossover Early Phase 1 Pilot Study to Assess Safety and Pharmacokinetics of a Tenofovir Disoproxil Fumarate and Emtricitabine (TDF-FTC) Releasing IVR Over 28 Days Compared to Placebo

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Oak Crest Institute of Science · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by randomization to order with 5 participants per study arm. All participants will sequentially receive both study products for 28-days with at least a 2-week washout period between products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC pod-IVR during Stage 3. During Stages 2 \& 3 participants will also complete brief phone surveys (\<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs) regarding perceptibility and acceptability. If willing, participants' male sexual partners will be invited to complete IDIs as well.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
DRUG	Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC)	TDF-FTC pod-IVR designed to deliver TDF at a target rate of 1 mg d-1 and FTC at a target rate of 2 mg d-1.
OTHER	Placebo	A placebo pod-IVR containing microcrystalline cellulose pods.

Timeline

• Start date: 2018-09-20
• Primary completion: 2020-09-30
• Completion: 2025-12-31
• First posted: 2017-08-21
• Last updated: 2023-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study