NCT01369303

Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel

Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel Using the Bat 24 Regimen Versus Daily and Pericoital Dosing

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to obtain data on the pharmacokinetics (PK) and pharmacodynamics (PD) and immune system effect of the BAT24 dosing regimen versus daily and pericoital dosing regimens with vaginal use of tenofovir 1% gel after a single sex act and after multiple sex acts.

Conditions

• Prevention

Interventions

Type	Name	Description
DRUG	Tenofovir 1% vaginal gel	Tenofovir 1% gel is supplied as a clear, transparent, viscous gel packaged in pre-filled single use applicators. Each applicator contains 4.0 mL of tenofovir gel (equal to 4.4 gm) at a concentration of 1% (weight for weight) formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben and hydroxyethylcellulose, and is pH adjusted to 4-5.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-06-08
• Last updated: 2013-12-12

Locations

5 sites across 2 countries: United States, Dominican Republic