Evidence map›Paper›PMID 40590452›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Bone Changes With Long-Acting Cabotegravir or Tenofovir Disoproxil Fumarate/Emtricitabine for HIV Prevention in Cisgender Men and Transgender Women: HPTN 083.

Todd T Brown, Robert F Arao, Maryam Warsi, Nittaya Phanuphak, Ricardo Vasconcelos, Temitope Oyedele, Philip A Sullivan, Brett Hanscom, James F Rooney, Alex R Rinehart and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02720094 (A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women Who Have Sex With Men), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT02720094 phase2 / phase3completednot on this map

A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine For Pre-Exposure Prophylaxis in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2016 to 2025Enrolled4,570ConditionsHIV InfectionsArmsCabotegravir Oral Tablet, TDF/FTC tablets, Placebo for TDF/FTC tablets, Placebo for cabotegravir oral tablet, CAB LA
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

13 authors.

Todd T BrownDepartment of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.ORCID 0000-0001-8599-278X
Robert F AraoFred Hutchinson Cancer Center, Seattle, Washington, USA.
Maryam WarsiFred Hutchinson Cancer Center, Seattle, Washington, USA.
Nittaya PhanuphakInstitute of HIV Research and Innovation, Bangkok, Thailand.
Ricardo VasconcelosDepartment of Infectious and Parasitic Diseases, University of Sao Paulo, Sao Paolo, Brazil.ORCID 0000-0002-9753-0563
Temitope OyedeleAstra Zeneca, Gaithersburg, Maryland, USA.
Philip A SullivanDepartment of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Brett HanscomFred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0003-0618-2979
James F RooneyGilead Sciences, Foster City, California, USA.
Alex R RinehartViiV Healthcare, Chapel Hill, North Carolina, USA.
Marybeth McCauleyFHI 360, Washington, DC, USA.
Beatriz GrinsztejnInstituto Nacional de Infectologia Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil.
Raphael J LandovitzDepartment of Medicine, University of California-Los Angeles, Los Angeles, California, USA.ORCID 0000-0002-1442-714X

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
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
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)UM1AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI BEATRIZ GRINSZTEJN · 2012 to 2026
$26.3M
The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit (FioTrials)U01AI069476 · NIAID · FUNDACAO OSWALDO CRUZ · PI GRINSZTEJN, BEATRIZ · 2008 to 2011
$14.0M
NIAID NIH HHS U01 AI069476NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069476
6 · The paper itself

Abstract

In a randomized clinical trial, pre-exposure prophylaxis (PrEP) with long-acting cabotegravir (CAB-LA) had a better bone safety profile than tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) over 105 weeks. For individuals with low bone mineral density or other fracture risk factors, CAB-LA PrEP should be considered over TDF-based PrEP. Clinical Trials Registration.  clinicaltrials.gov (NCT02720094).

Indexed as

Anti-HIV AgentsEmtricitabineEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationHIV InfectionsPre-Exposure ProphylaxisPyridonesTenofovirAdultBone DensityDiketopiperazinesFemaleHumansMaleMiddle AgedTransgender PersonsYoung AdultAnti-HIV AgentscabotegravirDiketopiperazinesEmtricitabineEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationPyridonesTenofovirbone mineral densitycabotegravirHIV pre-exposure prophylaxistenofovir disoproxil fumarate

Identifiers

PMID40590452
PMCPMC12249367

What OpenQuestion holds

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Registered trials

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.