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J Infect Dis. 2017 Jan 15;215(2):238-246. doi: 10.1093/infdis/jiw525.

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).

Author information

1
Department of Medicine, Weill Cornell Medicine, New York.
2
Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center.
3
Department of Medicine, University of California, Los Angeles.
4
Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor.
5
Department of Pathology.
6
Department of Medicine, Johns Hopkins University School of Medicine.
7
Department of Medicine, University of Pittsburgh School of Medicine.
8
Department of Medicine, University of North Carolina, Chapel Hill.
9
HIV Research Branch.
10
Clinical Prevention Research Branch, Prevention Sciences Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
11
ViiV Healthcare.
12
Gilead Sciences, Foster City.
13
FHI 360, Durham, North Carolina.
14
Department of Medicine, Case Western Reserve University, Cleveland, Ohio.
15
Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, George Washington University.
16
Johns Hopkins University School of Nursing, Baltimore.
17
Bridge HIV, San Francisco Department of Public Health, California.
18
Department of Medicine, Perelman School of Medicine of the University of Pennsylvania, Philadelphia.
19
Department of Medicine, University of Puerto Rico School of Medicine, San Juan.
20
Department of Medicine, University of Washington, Seattle.
21
FHI 360, Washington, DC.
22
Fenway Health, Department of Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts.

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; PrEP; maraviroc; men who have sex with men (MSM); phase 2 clinical trial

PMID:
27811319
PMCID:
PMC5790146
DOI:
10.1093/infdis/jiw525
[Indexed for MEDLINE]
Free PMC Article

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