NCT03670355

Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir

A Phase 1, Randomized Pharmacokinetic and Safety Study of a 90 Day Intravaginal Ring Containing Tenofovir

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of a 90-day intravaginal ring (IVR) containing tenofovir (TFV).

Detailed description

This study will evaluate the pharmacokinetics (PK) and safety of a 90-day intravaginal ring (IVR) containing tenofovir (TFV) in healthy, HIV-uninfected individuals assigned female sex at birth. Participants will be randomly assigned to receive an IVR containing either 1.4 g TFV or placebo. The IVR will be inserted at the enrollment visit (Day 0) and used continuously for approximately 91 days. Additional study visits will occur at Days 1, 7, 14, 28, 42, 56, 91, and 92. Study visits may include behavioral assessments, physical examinations, blood and urine collection, and pelvic and rectal specimen collection.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Tenofovir (TFV) IVR	Contains 1.4 g TFV
DRUG	Placebo IVR	Contains placebo

Timeline

• Start date: 2019-01-02
• Primary completion: 2019-09-25
• Completion: 2019-09-25
• First posted: 2018-09-13
• Last updated: 2025-11-13
• Results posted: 2025-11-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study