Format

Send to

Choose Destination
Clin Infect Dis. 2017 Mar 1;64(5):614-620. doi: 10.1093/cid/ciw832.

MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel.

Author information

1
University of Pittsburgh, Pennsylvania, USA.
2
Asociación Civil Impacta Salud y Educación, Lima, Peru.
3
Department of Biostatistics, University of Washington, Box 359909, Seattle, WA, USA.
4
Fred Hutchinson Cancer Research Center-Statistical Center for HIV/AIDS Research and Prevention, Seattle, Washington, USA.
5
New York State Psychiatry Institute and Columbia University, New York, USA.
6
Magee-Womens Research Institute, Pittsburgh, Pennsylvania, USA.
7
Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
8
FHI 360, Durham, North Carolina, USA.
9
National Institute of Allergy and Infectious Disease/DAIDS, Rockville, MD, USA..
10
National Institute of Mental Health, Bethesda, Maryland, USA.
11
AIDS Foundation of Chicago, Illinois, USA.
12
Desmond Tutu HIV Centre, University of Cape Town, South Africa.
13
Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, Thailand.
14
Thailand Ministry of Public Health-US Centers for Disease Control and Prevention Collaboration, Bangkok, Thailand.
15
Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
16
Bridge HIV, San Francisco Department of Public Health, California, USA.
17
Fenway Institute, Boston, Massachusetts, USA.
18
Department of Obstetrics and Gynecology, University of Puerto Rico School of Medicine, San Juan, USA.
19
CONRAD/Eastern Virginia Medical School, Arlington, Virginia, USA.
20
Gilead Sciences, Foster City, California, USA.

Abstract

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.

Clinical Trials Registration:

NCT01687218.

KEYWORDS:

HIV; microbicide; prevention; rectal; tenofovir

PMID:
27986684
PMCID:
PMC5850518
DOI:
10.1093/cid/ciw832
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center