@article{30c90631acf340169c9f6cbb8f863b25,
title = "Phase 2 study of the safety and tolerability of maraviroc-containing regimens to prevent HIV infection in men who have sex with men (HPTN 069/ACTG A5305)",
abstract = "Background. Maraviroc (MVC) is a candidate for human immunodeficiency virus (HIV) pre-exposure prophylaxis. Methods. Phase 2 48-week safety/tolerability study was conducted, comparing 4 regimens: MVC alone, MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF plus FTC. Eligible participants were HIV-uninfected men and transgender women reporting condomless anal intercourse with ≥1 HIV-infected or unknown-serostatus man within 90 days. At each visit, assessments, laboratory testing, and counseling were done. Analyses were intention to treat. Results. Among 406 participants, 84% completed follow-up, 7% stopped early, and 9% were lost to follow-up; 9% discontinued their regimen early. The number discontinuing and the time to discontinuation did not differ among study regimens (P = .60). Rates of grade 3-4 adverse events did not differ among regimens (P = .37). In a randomly selected subset, 77% demonstrated detectable drug concentrations at week 48. Five participants acquired HIV infection (4 MVC alone, 1 MVC + TDF; overall annualized incidence, 1.4% [95% confidence interval, .5%-3.3%], without differences by regimen; P = .32); 2 had undetectable drug concentrations at every visit, 2 had low concentrations at the seroconversion visit, and 1 had variable concentrations. Conclusions. MVC-containing regimens were safe and well tolerated compared with TDF + FTC; this study was not powered for efficacy. Among those acquiring HIV infection, drug concentrations were absent, low, or variable. MVC-containing regimens may warrant further study for pre-exposure prophylaxis. Clinical Trials Registration. NCT01505114.",
keywords = "HIV, Maraviroc, Men who have sex with men (MSM), Phase 2 clinical trial002E, PrEP",
author = "Gulick, {Roy M.} and Wilkin, {Timothy J.} and Chen, {Ying Q.} and Landovitz, {Raphael J.} and {Rivet Amico}, K. and Young, {Alicia M.} and Paul Richardson and Marzinke, {Mark A.} and Hendrix, {Craig W.} and Eshleman, {Susan H.} and Ian McGowan and Cottle, {Leslie M.} and Adriana Andrade and Cheryl Marcus and Klingman, {Karin L.} and Wairimu Chege and Rinehart, {Alex R.} and Rooney, {James F.} and Philip Andrew and Salata, {Robert A.} and Manya Magnus and Farley, {Jason E.} and Albert Liu and Ian Frank and Ken Ho and Jorge Santana and Stekler, {Joanne D.} and Marybeth McCauley and Mayer, {Kenneth H.}",
note = "Funding Information: Potential conflicts of interest. T. J. W. has received research grants (to Weill Cornell) from Gilead Sciences and served as an ad hoc consultant to GlaxoSmithKline/ViiV. R. J. L. has received drug supplies, consulting fees, and travel costs from Gilead Sciences. K. R. A. has received an educational grant (to the University of Michigan) and served as an ad-hoc consultant to Gilead Sciences. C. W. H. has received a research grant (through Johns Hopkins) from Gilead Sciences and served as an ad hoc consultant to GlaxoSmithKline/ViiV. S. H. E. has participated in collaborative research studies with Monogram Biosciences. I. M. has received consulting fees from Novicol Life Sciences and ABIVAX and research grants from Janssen R and D and ViiV Healthcare. A. A. received an honorarium from Bristol-Myers Squibb for a continuing medical education program and research grants from Gilead and GlaxoSmithKline for investigator-initiated studies. A. R. R. is an employee and stockholder in ViiV Healthcare. J. F. R. is an employee and stockholder in Gilead Sciences. M. Magnus has received royalties from Jones and Bartlett Learning for textbook Funding Information: Financial support. This work was supported by DAIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health through the HPTN (grants UM1-AI068619, UM1-AI068613, and UM1-AI068617) and the AIDS Clinical Trials Group (grant UM1-AI-068636). Gilead Sciences and ViiV Healthcare provided study drugs. Publisher Copyright: {\textcopyright} The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. Copyright: Copyright 2018 Elsevier B.V., All rights reserved.",
year = "2017",
month = jan,
day = "15",
doi = "10.1093/infdis/jiw525",
language = "English (US)",
volume = "215",
pages = "238--246",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Oxford University Press",
number = "2",
}