title: MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  NCT01687218.
authors.affiliation: University of Pittsburgh, Pennsylvania, USA.
authors.forename: Ross D
authors.initials: RD
authors.lastname: Cranston
authors.affiliation: Asociación Civil Impacta Salud y Educación, Lima, Peru.
authors.forename: Javier R
authors.initials: JR
authors.lastname: Lama
authors.affiliation: Department of Biostatistics, University of Washington, Box 359909, Seattle, WA, USA.|Fred Hutchinson Cancer Research Center-Statistical Center for HIV/AIDS Research and Prevention, Seattle, Washington, USA.
authors.forename: Barbra A
authors.initials: BA
authors.lastname: Richardson
authors.affiliation: New York State Psychiatry Institute and Columbia University, New York, USA.
authors.forename: Alex
authors.initials: A
authors.lastname: Carballo-Diéguez
authors.affiliation: Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.
authors.forename: Ratiya Pamela
authors.initials: RP
authors.lastname: Kunjara Na Ayudhya
authors.affiliation: Fred Hutchinson Cancer Research Center-Statistical Center for HIV/AIDS Research and Prevention, Seattle, Washington, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Liu
authors.affiliation: Fred Hutchinson Cancer Research Center-Statistical Center for HIV/AIDS Research and Prevention, Seattle, Washington, USA.
authors.forename: Karen B
authors.initials: KB
authors.lastname: Patterson
authors.affiliation: New York State Psychiatry Institute and Columbia University, New York, USA.
authors.forename: Cheng-Shiun
authors.initials: CS
authors.lastname: Leu
authors.affiliation: Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.
authors.forename: Beth
authors.initials: B
authors.lastname: Galaska
authors.affiliation: Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.
authors.forename: Cindy E
authors.initials: CE
authors.lastname: Jacobson
authors.affiliation: University of Pittsburgh, Pennsylvania, USA.
authors.forename: Urvi M
authors.initials: UM
authors.lastname: Parikh
authors.affiliation: Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Marzinke
authors.affiliation: Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Craig W
authors.initials: CW
authors.lastname: Hendrix
authors.affiliation: FHI 360, Durham, North Carolina, USA.
authors.forename: Sherri
authors.initials: S
authors.lastname: Johnson
authors.affiliation: National Institute of Allergy and Infectious Disease/DAIDS, Rockville, MD, USA..
authors.forename: Jeanna M
authors.initials: JM
authors.lastname: Piper
authors.affiliation: National Institute of Mental Health, Bethesda, Maryland, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Grossman
authors.affiliation: University of Pittsburgh, Pennsylvania, USA.
authors.forename: Ken S
authors.initials: KS
authors.lastname: Ho
authors.affiliation: FHI 360, Durham, North Carolina, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Lucas
authors.affiliation: AIDS Foundation of Chicago, Illinois, USA.
authors.forename: Jim
authors.initials: J
authors.lastname: Pickett
authors.affiliation: Desmond Tutu HIV Centre, University of Cape Town, South Africa.
authors.forename: Linda-Gail
authors.initials: LG
authors.lastname: Bekker
authors.affiliation: Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.
authors.forename: Suwat
authors.initials: S
authors.lastname: Chariyalertsak
authors.affiliation: Thailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand.
authors.forename: Anupong
authors.initials: A
authors.lastname: Chitwarakorn
authors.affiliation: Asociación Civil Impacta Salud y Educación, Lima, Peru.
authors.forename: Pedro
authors.initials: P
authors.lastname: Gonzales
authors.affiliation: Thailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand.|Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
authors.forename: Timothy H
authors.initials: TH
authors.lastname: Holtz
authors.affiliation: Bridge HIV, San Francisco Department of Public Health, California, USA.
authors.forename: Albert Y
authors.initials: AY
authors.lastname: Liu
authors.affiliation: Fenway Institute, Boston, Massachusetts, USA.
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
authors.affiliation: Department of Obstetrics and Gynecology, University of Puerto Rico School of Medicine, San Juan, USA.
authors.forename: Carmen
authors.initials: C
authors.lastname: Zorrilla
authors.affiliation: CONRAD/Eastern Virginia Medical School, Arlington, Virginia, USA.
authors.forename: Jill L
authors.initials: JL
authors.lastname: Schwartz
authors.affiliation: Gilead Sciences, Foster City, California, USA.
authors.forename: James
authors.initials: J
authors.lastname: Rooney
authors.affiliation: University of Pittsburgh, Pennsylvania, USA.
authors.forename: Ian
authors.initials: I
authors.lastname: McGowan
mesh_terms: D000293:Adolescent; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D005782:Gels; D005990:Glycerol; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D012007:Rectum / Q000187:drug effects* / Q000821:virology*; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000068698:Tenofovir / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005782:Gels; D018894:Reverse Transcriptase Inhibitors; D000068698:Tenofovir; D005990:Glycerol
keywords: HIV; microbicide; prevention; rectal; tenofovir