Study title
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
Study Codename
MTN 017
Network
Microbicide Trial Network
Study PI
Prof. Suwat Chariyalertsak, M.D, DrPH
Study Co Investigator
Taweewat Supindham, M.D
Study sites
PIMAN clinic, 35-7-8 Soi 13 Nimmarnhaemin road, Tumbon Suthep, Amphur Muang, Chiang Mai
Funding agency
Division of AIDS (DAIDS)
US National Institute of Allergy and Infectious Disease (NIAID)
US National Institute of Mental Health
National Institute of Health (NIH)
Study design
Phase 2, multi-site, randomized, six-sequence, three-period, open label crossover study
Study Regimen: Participants will receive emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) tablet (Truvada®) and tenofovir (TFV) reduced-glycerin (RG) 1% gel
Study objective
• Safety: To compare
the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel
• Acceptability: To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel
Number of participants to be enrolled (overall/at RIHES)
186 participants (overall)/ 30 RIHES
Year: started
2013
Year: expected to finish
2015
Status
Follow up participant
Significance
The information that learned in this study may lead to the development of safe and effective interventions to prevent HIV transmission
Study website (if any)
www.pimancenter.com
www.mtnstopshiv.org