Evidence map›Paper›PMID 34791296›Full record

Trial reportThe Journal of antimicrobial chemotherapy2022

Bone changes with candidate PrEP regimens containing tenofovir disoproxil fumarate and/or maraviroc and/or emtricitabine in US men and women: HPTN 069/ACTG A5305.

Todd T Brown, Krista Yuhas, Kenneth H Mayer, Raphael J Landovitz, Mark A Marzinke, Craig W Hendrix, Ying Q Chen, Karen L Klingman, Wairimu Chege, Marybeth B Mccauley and 2 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 23% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Bone Changes With Long-Acting Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention in Cisgender Men and Transgender Women: HPTN 083.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Trial
  2. Cardiometabolic health in people with HIV: expert consensus review.The Journal of antimicrobial chemotherapy · 2024
    Review
  3. Article
  4. 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

12 authors at 7 institutions in 1 country.

Todd T BrownDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.ORCID 0000-0001-8599-278X
Krista YuhasStatistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.
Kenneth H MayerFenway Health, Department of Medicine, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA 02215, USA.
Raphael J LandovitzDepartment of Medicine, University of California, Los Angeles, Los Angeles,, CA 90025, USA.
Mark A MarzinkeDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
Craig W HendrixDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA.
Ying Q ChenStatistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.
Karen L KlingmanHIV Research Branch, Therapeutics Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Wairimu ChegeClinical Prevention Research Branch, Prevention Sciences Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Marybeth B MccauleyFHI 360, 1825 Connecticut Avenue NW, Washington, DC 20009, USA.
Roy M GulickDepartment of Medicine, Weill, Cornell, Medicine, New York, NY 10065, USA.
Timothy J WilkinDepartment of Medicine, Weill, Cornell, Medicine, New York, NY 10065, USA.
Johns Hopkins University · USCornell University · USFred Hutch Cancer Center · USNational Institutes of Health · USBeth Israel Deaconess Medical Center · USFamily Health International 360 · USUniversity of California, Los Angeles · 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 MYRON Scott COHEN, Sinead Delany-Moretlwe · 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
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
$100.2M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials UnitUM1AI069419 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI ROY M. GULICK · 2012 to 2026
$44.6M
Leadership for HIV/AIDS Clinical Trials Networks; HIV Prevention Trials NetworkU01AI068617 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DONNELL, DEBORAH J · 2006 to 2010
$28.8M
NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069424NIH HHS UM1-AI068619NIH HHS UM1-AI-068636
6 · The paper itself

Abstract

backgroundTenofovir disoproxil fumarate-containing pre-exposure prophylaxis (PrEP) has been associated with decreases in bone mineral density (BMD), but the bone effects of other non-tenofovir disoproxil fumarate candidate PrEP regimens are not well described.

methodsThe HPTN 069/ACTG A5305 study randomized 406 US cisgender men and transgender women, and 188 cisgender women at risk for HIV infection to one of four double-blinded regimens: (i) maraviroc; (ii) maraviroc + emtricitabine; (iii) maraviroc + tenofovir disoproxil fumarate; or (iv) tenofovir disoproxil fumarate + emtricitabine. BMD was measured in a subset of participants at the lumbar spine (LS) and hip by dual-energy X-ray absorptiometry (DXA) at baseline and 48 weeks. Percentage change in LS and hip BMD was compared between the tenofovir disoproxil fumarate- and non-tenofovir disoproxil fumarate-containing arms by Wilcoxon rank-sum tests and multiple linear regression adjusting for sex, race and baseline BMI.

resultsAt baseline (n = 307), the median age was 33 years, 56% male and 43% black. At the hip, the median percentage change in BMD at 48 weeks was -1.05% in the tenofovir disoproxil fumarate arms and 0.0% in the non-tenofovir disoproxil fumarate arms (between group P = 0.001). No interaction by sex was observed. The median percentage change in LS BMD was not different between arms.

conclusionsTenofovir disoproxil fumarate-containing PrEP was associated with significantly greater bone loss compared with maraviroc ± emtricitabine PrEP at the hip, but not the LS. The BMD changes at the hip were similar in magnitude in men and women.

Indexed as

Anti-HIV AgentsHIV InfectionsAdultDouble-Blind MethodEmtricitabineFemaleHumansMaleMaravirocTenofovirAnti-HIV AgentsEmtricitabineMaravirocTenofovir

Identifiers

PMID34791296
PMCPMC9097256
OpenAlexW3211805516

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.