NCT02722343

Exploratory Pharmacodynamic Study of Tenofovir-Based Products

Phase I Exploratory Pharmacodynamic Study of Tenofovir-Based Products

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This single site study is designed to describe and measure the efficacy of oral versus vaginal dosing of TFV-based products, specifically emtricitabine/tenofovir disoproxil fumarate oral tablets (Truvada) vs tenofovir intravaginal rings (IVR).

Detailed description

This study will compare an investigational intravaginal ring containing tenofovir (TFV) with an FDA approved medication in tablet form called Truvada®. It will assess and compare the ability of the tablet and intravaginal ring to prevent HIV transmission (human immunodeficiency virus, the virus that causes AIDS). The study will enroll healthy, non-pregnant, HIV negative, premenopausal women (aged 18-50, with regular menstrual cycles) who are not at risk of pregnancy. The enrollment goal is for 20 participants to complete the study. Participants will be assigned to use one of the study products: oral tablet or intravaginal ring. Participants will take the oral tablet each day for 14 days or wear the intravaginal ring all day and night for 14 days/nights. Blood, genital fluid samples and genital tissue samples (biopsies) will be taken at two visits. These sample collections will take place before and after use of the assigned study product. The samples will be tested to: 1. Determine the levels of drug in the blood and genital tissue samples 2. See if the samples taken from the vagina and cervix after use of study product, provides protection from HIV in the laboratory 3. Ensure that the laboratory test used to measure HIV infection in the samples performs well when used repeatedly. In addition this study will also evaluate the returned TFV rings to see whether they were used as instructed.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Tenofovir intravaginal ring	The participant will wear the intravaginal ring consecutively for 14 days and nights. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue)
DRUG	Truvada	The participant will take the tablet for 14 days. taking one tablet each morning. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue)

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-03-30
• Last updated: 2016-09-02

Locations

1 site across 1 country: United States