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

NCT03670355 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-11-13

Study results available
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Summary

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

Conditions

  • HIV Infections

Interventions

DRUG

Tenofovir (TFV) IVR

Contains 1.4 g TFV

DRUG

Placebo IVR

Contains placebo

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Albert Liu, MD, MPH · San Francisco Department of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-09-25
Completion
2019-09-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03670355 on ClinicalTrials.gov