Evidence map›Paper›PMID 28828489›Full record

Trial reportAnnals of internal medicine2017

Safety and Tolerability of Maraviroc-Containing Regimens to Prevent HIV Infection in Women: A Phase 2 Randomized Trial.

Roy M Gulick, Timothy J Wilkin, Ying Q Chen, Raphael J Landovitz, K Rivet Amico, Alicia M Young, Paul Richardson, Mark A Marzinke, Craig W Hendrix, Susan H Eshleman and 20 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of internal medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01505114 (A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.6field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01505114 phase2completednot on this map

A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir Disoproxil Fumarate (MVC+TDF), or Tenofovir Disoproxil Fumarate + Emtricitabine (TDF+FTC) For Pre-Exposure Prophylaxis (PrEP) To Prevent HIV Transmission in At-Risk Men Who Have Sex With Men and in At-Risk Women

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2012 to 2015Enrolled594ConditionsHIV InfectionArmsMaraviroc, Emtricitabine, Tenofovir disoproxil fumarate, Maraviroc placebo, Emtricitabine placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 31 citations in OpenAlex.

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  16. Results from a Pre-exposure Prophylaxis Demonstration Project for At-risk Cisgender Women in the United States.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Observational
  17. Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors at 11 institutions in 1 country.

Roy M GulickFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Timothy J WilkinFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Ying Q ChenFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Raphael J LandovitzFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
K Rivet AmicoFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Alicia M YoungFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Paul RichardsonFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Mark A MarzinkeFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Craig W HendrixFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Susan H EshlemanFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Ian McGowanFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Leslie M CottleFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Adriana AndradeFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Cheryl MarcusFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Karin L KlingmanFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Wairimu ChegeFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Alex R RinehartFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
James F RooneyFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Philip AndrewFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Robert A SalataFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Marc SiegelFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Yukari C ManabeFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Ian FrankFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Ken HoFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Jorge SantanaFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Joanne D SteklerFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Shobha SwaminathanFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Marybeth McCauleyFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Sally HodderFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Kenneth H MayerFrom Weill Cornell Medicine, New York, New York; Fred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington; University of California, Los Angeles, Los Angeles, California; University of Michigan, Ann Arbor, Michigan; Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Pittsburgh and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; University of North Carolina, Chapel Hill, North Carolina; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland; ViiV Healthcare, Durham, North Carolina; Gilead Sciences, Foster City, California; Case Western Reserve University, Cleveland, Ohio; The George Washington University and FHI 360, Washington, DC; Perelman School of Medicine of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Rutgers New Jersey Medical School, Newark, New Jersey; West Virginia University, Morgantown, West Virginia; and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Fred Hutch Cancer Center · USJohns Hopkins University · USNational Institutes of Health · USNational Institute of Allergy and Infectious Diseases · USUniversity of Michigan–Ann Arbor · USUniversity of Washington · USCornell University · USCase Western Reserve University · USGeorge Washington University · USUniversity of Pennsylvania · USUniversity of Pittsburgh · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI Sinead Delany-Moretlwe, RAPHAEL J LANDOVITZ · 2011 to 2026
$779.5M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
SDMC: HPTN 084 Pregnancy SupplementUM1AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Elizabeth Renata Brown, Deborah J Donnell · 2011 to 2026
$204.9M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
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Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
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West Virginia IDEA-CTRU54GM104942 · NIGMS · WEST VIRGINIA UNIVERSITY · PI JUDITH FEINBERG · 2012 to 2026
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Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ronald G Collman · 1999 to 2026
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UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
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6 · The paper itself

Abstract

backgroundMaraviroc (MVC) is a candidate drug for HIV preexposure prophylaxis (PrEP).

objectiveTo assess the safety and tolerability of MVC-containing PrEP over 48 weeks in U.S. women at risk for HIV infection.

designPhase 2 randomized, controlled, double-blinded study of 4 antiretroviral regimens used as PrEP. (ClinicalTrials.gov: NCT01505114).

setting12 clinical research sites of the HIV Prevention Trials Network and AIDS Clinical Trials Group.

participantsHIV-uninfected women reporting condomless vaginal or anal intercourse with at least 1 man with HIV infection or unknown serostatus within 90 days.

interventionMVC only, MVC-emtricitabine (FTC), MVC-tenofovir disoproxil fumarate (TDF), and TDF-FTC (control). MEASUREMENTS: At each visit, clinical and laboratory (including HIV) assessments were done. Primary outcomes were grade 3 and 4 adverse events and time to permanent discontinuation of the study regimen. All randomly assigned participants were analyzed according to their original assignment.

resultsAmong 188 participants, 85% completed follow-up, 11% withdrew early, and 4% were lost to follow-up; 19% discontinued their regimen prematurely. The number discontinuing and the time to discontinuation did not differ among regimens. Grade 3 or 4 adverse events occurred in 5 (MVC), 13 (MVC-FTC), 9 (MVC-TDF), and 8 (TDF-FTC) participants; rates did not differ among regimens. One death (by suicide) occurred in the MVC-TDF group but was judged not to be related to study drugs. Of available plasma samples at week 48 (n = 126), 60% showed detectable drug concentrations. No new HIV infections occurred. LIMITATIONS: Participants were not necessarily at high risk for HIV infection. The regimen comprised 3 pills taken daily. The study was not powered for efficacy.

conclusionMaraviroc-containing PrEP regimens were safe and well-tolerated compared with TDF-FTC in U.S. women. No new HIV infections occurred, although whether this was due to study drugs or low risk in the population is uncertain. Maraviroc-containing PrEP for women may warrant further study. PRIMARY FUNDING SOURCE: National Institutes of Health.

Indexed as

Pre-Exposure ProphylaxisAdolescentAdultCyclohexanesDouble-Blind MethodFemaleFollow-Up StudiesHIV Fusion InhibitorsHIV InfectionsHumansMaravirocMiddle AgedPatient DropoutsProspective StudiesTreatment OutcomeTriazolesCyclohexanesHIV Fusion InhibitorsMaravirocTriazoles

Identifiers

PMID28828489
PMCPMC5667908
OpenAlexW2760062664

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