MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel

© The Author 2017. Background. Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. Methods. MTN-017 was a phase 2, 3-period, randomized sequenc...

Full description

Saved in:
Bibliographic Details
Main Authors: Cranston R., Lama J., Richardson B., Carballo-Diéguez A., Na Ayudhya R., Liu K., Patterson K., Leu C., Galaska B., Jacobson C., Parikh U., Marzinke M., Hendrix C., Johnson S., Piper J., Grossman C., Ho K., Lucas J., Pickett J., Bekker L., Chariyalertsak S., Chitwarakorn A., Gonzales P., Holtz T., Liu A., Mayer K., Zorrilla C., Schwartz J., Rooney J., McGowan I.
Format: Journal
Published: 2017
Online Access:https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85018192380&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/41179
Tags: Add Tag
No Tags, Be the first to tag this record!
Institution: Chiang Mai University
id th-cmuir.6653943832-41179
record_format dspace
spelling th-cmuir.6653943832-411792017-09-28T04:16:06Z MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel Cranston R. Lama J. Richardson B. Carballo-Diéguez A. Na Ayudhya R. Liu K. Patterson K. Leu C. Galaska B. Jacobson C. Parikh U. Marzinke M. Hendrix C. Johnson S. Piper J. Grossman C. Ho K. Lucas J. Pickett J. Bekker L. Chariyalertsak S. Chitwarakorn A. Gonzales P. Holtz T. Liu A. Mayer K. Zorrilla C. Schwartz J. Rooney J. McGowan I. © The Author 2017. Background. Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. Methods. MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/ TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. Results. MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in ≥grade 2 adverse event rates between daily gel (incidence rate ratio [IRR] , 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (≥80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio [OR] , 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001). Conclusions. Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen. 2017-09-28T04:16:06Z 2017-09-28T04:16:06Z 2017-01-01 Journal 10584838 2-s2.0-85018192380 10.1093/cid/ciw832 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85018192380&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/41179
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
description © The Author 2017. Background. Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. Methods. MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/ TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. Results. MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in ≥grade 2 adverse event rates between daily gel (incidence rate ratio [IRR] , 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (≥80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio [OR] , 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001). Conclusions. Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen.
format Journal
author Cranston R.
Lama J.
Richardson B.
Carballo-Diéguez A.
Na Ayudhya R.
Liu K.
Patterson K.
Leu C.
Galaska B.
Jacobson C.
Parikh U.
Marzinke M.
Hendrix C.
Johnson S.
Piper J.
Grossman C.
Ho K.
Lucas J.
Pickett J.
Bekker L.
Chariyalertsak S.
Chitwarakorn A.
Gonzales P.
Holtz T.
Liu A.
Mayer K.
Zorrilla C.
Schwartz J.
Rooney J.
McGowan I.
spellingShingle Cranston R.
Lama J.
Richardson B.
Carballo-Diéguez A.
Na Ayudhya R.
Liu K.
Patterson K.
Leu C.
Galaska B.
Jacobson C.
Parikh U.
Marzinke M.
Hendrix C.
Johnson S.
Piper J.
Grossman C.
Ho K.
Lucas J.
Pickett J.
Bekker L.
Chariyalertsak S.
Chitwarakorn A.
Gonzales P.
Holtz T.
Liu A.
Mayer K.
Zorrilla C.
Schwartz J.
Rooney J.
McGowan I.
MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel
author_facet Cranston R.
Lama J.
Richardson B.
Carballo-Diéguez A.
Na Ayudhya R.
Liu K.
Patterson K.
Leu C.
Galaska B.
Jacobson C.
Parikh U.
Marzinke M.
Hendrix C.
Johnson S.
Piper J.
Grossman C.
Ho K.
Lucas J.
Pickett J.
Bekker L.
Chariyalertsak S.
Chitwarakorn A.
Gonzales P.
Holtz T.
Liu A.
Mayer K.
Zorrilla C.
Schwartz J.
Rooney J.
McGowan I.
author_sort Cranston R.
title MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel
title_short MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel
title_full MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel
title_fullStr MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel
title_full_unstemmed MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel
title_sort mtn-017: a rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel
publishDate 2017
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85018192380&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/41179
_version_ 1681421954348744704