MTN-017: A Phase 2 Randomized Expanded Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel
Suwat Chariyalertsak, MD, DrPH
Ross D. Cranston, MD, FRCP
Linda-Gail Bekker, MBChB, PhD
Pedro Gonzales, MD, MAS
Timothy H. Holtz, MD, MPH, FACP
Albert Liu, MD, MPH
Kenneth Mayer, MD
Carmen D. Zorrilla, MD
Chiang Mai University, Chiang Mai, Thailand
Pitt Clinical Research Site, University of Pittsburgh, Pittsburgh, PA, USA
Desmond Tutu HIV Foundation Clinical Research Site, University of Cape Town, Cape Town, South Africa
San Miguel Clinical Research Site, IMPACTA, Lima, Peru
Silom Community Clinic Clinical Research Site, Bangkok, Thailand
San Francisco Vaccine and Prevention Clinical Research Site, Department of Public Health, San Francisco, CA, USA
Fenway Clinical Research Site, Fenway Community Health, Boston, MA, USA
Puerto Rico CEMI Clinical Research Site, University of Puerto Rico, San Juan, PR
Chiang Mai, and Bangkok, Thailand;
Cape Town, South Africa
San Francisco, CA, USA
Boston, MA, USA
Pittsburgh, PA, USA
San Juan, PR
MTN-017 evaluated the safety and acceptability of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) tablet and rectally-applied tenofovir (TFV) reduced-glycerin (RG) 1% gel in international settings, where HIV prevalence is high, condom use is inconsistent and microbicides have been found to be acceptable among MSM.
The study was conducted with 187 men and transgender females who practice RAI at eight MTN study sites in Thailand, South Africa, Peru and the US. The study design was a phase 2, multi-site, randomized, six-sequence, three-period, open label crossover study in which participants used daily FTC/TDF tablet, daily RG 1% TFV gel, and RG 1% TFV gel in association with RAI. Dr. Carballo-Diéguez led the study’s behavioral team to assess acceptability and adherence to study products, employing web-based behavioral questionnaires, a short message service (SMS) diary, and in-depth phone interviews. In addition, Dr. Carballo-Diéguez, Dr. Balán and team designed a participant-centered adherence counseling intervention that was included at every study visit.
Cranston RD, Lama JR, Richardson BA, Carballo-Diéguez A, Kunjara Na Ayudkhya RP, Liu K, Patterson KB, Leu CS, Jacobson CE, Parikh UM, Marzinke MA, Hendrix CW, Johnson S, Piper JM, Grossman C, Ho KS, Lucas J, Pickett J, Bekker LG, Chariyalertsak S, Chitwarakorn A, Gonzales P, Holtz TH, Liu AY, Mayer KH, Zorrilla C, Schwartz JL, Rooney J, McGowan I, MTN-017 Protocol Team. (2017). MTN-017: A rectal phase 2 expanded safety and acceptability study of tenofovir reduced-glycerin 1% gel. Clin Infect Dis, 64(5):614-20.
- Brown III W, Giguere R, Sheinfil A, Balán I, Ibitoye M, Dolezal C, Ho T, Lama J, McGowan I, Cranston RD, Carballo-Diégeuz A, on behalf of the MTN-017 Protocol Team. Feasibility and Acceptability of an International SMS Text Message-based Adherence and Survey System in a Biomedical HIV Prevention Study (MTN-017). [P24.24] Poster presentation at HIVR4P Research for Prevention Conference, Chicago, USA, October 17-21, 2016.
- Balán I, Carballo-Diéguez A, Giguere R, Brown III W, Ho T, Dolezal C, McGowan I, Lama J, Cranston R, on behalf of the MTN-017 Protocol Team. Converging Self-reports, Product Returns, and Pharmacokinetic Results to Improve Adherence Measurement in MTN-017 - a Phase 2 Rectal Microbicide Study. [P24.11] Poster presentation at HIVR4P Research for Prevention Conference, Chicago, USA, October 17-21, 2016.
- Dolezal C, Rael C, Balán I, Giguere R, Leu C-S, Brown III W, Sheinfil A, Lama J, Cranston RD, McGowan I, Carballo-Diéguez A, on behalf of the MTN-017 Protocol TEam. The Association between Sexual Behavior and Acceptability of Oral PrEP and a Rectal Microbicide Gel to Prevent HIV Transmission. [P24.06] Poster presentation at HIVR4P Research for Prevention Conference, Chicago, USA, October 17-21, 2016.
- Carballo-Diéguez A, Balán IC, Giguere R, Dolezal C, Leu C-S, Brown III W, Ho T, Tuswa-Haynes C, Lama J, Piper J, Richardson B, McGowan I, Cranston RD, on behalf of the MTN-017 Protocol Team. High Levels of Adherence to a Rectal Microbicide Gel and to Oral PrEP Acheived in MTN-017. [A20.01] Oral presentation at HIVR4P Research for Prevention Conference, Chicago, USA, October 17-21, 2016.
- Giguere R, Brown III W, Balán I, Dolezal C, Ho T, Sheinfil A, Ibitoye M, Lama JR, McGowan I, Cranston RD, Carballo-Diéguez A. Are Participants Concerned about Privacy and Security when Using SMS to Report Product Adherence in a Rectal Microbicide Trial?  Poster presentation at the 11th International Conference on HIV Treatment and Prevention Adherence, Fort Lauderdale, FL, USA, May 9-11, 2016.
Carballo-Diéguez A, Giguere R, Dolezal C, Leu C-S, Balán IC, Brown III W, Lama JR, Richardson B, McGowan I, Cranston RD, on behalf of the MTN-017 Protocol Team: Preference of Oral PrEP Versus Rectal Tenofovir Microbicide Gel Regimens Among Men Who Have Sex With Men and Transgender Women Who Engage in Receptive Anal Intercourse.  Poster presentation at the 11th International Conference on HIV Treatment and Prevention Adherence, Fort Lauderdale, FL, May 9-11, 2016.