NCT01687218

Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

A Phase 2 Randomized Sequence Open Label Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel. The study population will be sexually active, HIV-uninfected males who are 18 years of age or older, who report a history of receptive anal intercourse in the past 3 months. Each of the study product regimens offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages will compare in terms of safety, acceptability, systemic and local absorption, and adherence will be examined within this study.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
DRUG	Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
DRUG	Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Timeline

• Start date: 2013-09-25
• Primary completion: 2015-05-26
• Completion: 2015-05-26
• First posted: 2012-09-18
• Last updated: 2021-06-24
• Results posted: 2017-02-01

Locations

8 sites across 5 countries: United States, Peru, Puerto Rico, South Africa, Thailand