Evidence map›Paper›PMID 39311597›Full record

Trial reportAntimicrobial agents and chemotherapy2024

Pharmacologic evaluation of delayed long-acting cabotegravir administration among cisgender women in HPTN 084.

Mark A Marzinke, Kelong Han, Brett Hanscom, Xu Guo, Estelle Piwowar-Manning, Craig W Hendrix, Scott Rose, Elizabeth Spooner, Carrie Mathew, Steven Innes and 9 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03164564 (A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03164564 phase3active not recruitingnot on this map

A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2026Enrolled3,224ConditionsHIV InfectionsArmsOral CAB, Oral TDF/FTC, Placebo for oral CAB, Placebo for oral TDF/FTC, CAB LA
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Observational
  2. Article
  3. 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

19 authors.

Mark A Marzinke *Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0003-1670-8786
Kelong Han *GSK, Collegeville, Pennsylvania, USA.ORCID 0000-0001-8010-9898
Brett HanscomVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Xu GuoVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Estelle Piwowar-ManningDepartment of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Craig W HendrixDivision of Clinical Pharmacology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Scott RoseFHI 360, Durham, North Carolina, USA.
Elizabeth SpoonerHIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.
Carrie MathewWits RHI, University of the Witwatersrand, Johannesburg, South Africa.
Steven InnesDesmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Rogers SekabiraBaylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.
Mercy MutambanengweFaculty of Medicine and Health Sciences, Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.
James F RooneyGilead Sciences, Foster City, California, USA.
Alex R RinehartViiV Healthcare, Durham, North Carolina, USA.
Adeola AdeyeyeDivision of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA.
Myron S CohenDivision of Infectious Diseases, Department of Medicine, University of North Carolina (UNC) at Chapel Hill, Chapel Hill, North Carolina, USA.
Mina HosseinipourDivision of Infectious Diseases, Department of Medicine, University of North Carolina (UNC) at Chapel Hill, Chapel Hill, North Carolina, USA.
Susan L FordGSK, Durham, North Carolina, USA.
Sinead Delany-MoretlweWits RHI, University of the Witwatersrand, Johannesburg, South Africa.

Funding

LOC: HIV Prevention Trials NetworkUM1AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI MYRON Scott COHEN, Sinead Delany-Moretlwe · 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
HIV Prevention trials Network (HPTN) Coordinating and Operations CenterU01AI068619 · NIAID · FAMILY HEALTH INTERNATIONAL · PI VERMUND, STEN H. · 2006 to 2010
$72.7M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
Bill and Melinda Gates Foundation (GF) OPP1154174HHS | NIH | National Institute of Allergy and Infectious Diseases (NIAID) UM1AI068613HHS | NIH | National Institute of Allergy and Infectious Diseases (NIAID) UM1AI068617HHS | NIH | National Institute of Allergy and Infectious Diseases (NIAID) UM1AI068619NIAID NIH HHS U01 AI068619NIAID NIH HHS U01 AI069463NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069463ViiV Healthcare (ViiV Healthcare Limited) NA
6 · The paper itself

Abstract

HPTN 084 demonstrated the superiority of long-acting injectable cabotegravir (CAB-LA) compared with daily oral tenofovir disoproxil fumarate-emtricitabine (F/TDF) for HIV prevention in women. CAB-LA (600 mg) or placebo injections were administered 4 weeks after an initial dose (loading dose) and every 2 months (Q2M) thereafter; this is the approved regimen. Participants experienced both loading dose and Q2M delays during the trial. CAB concentrations were evaluated before a delay, at the visit associated with the delay, and the visit after a delayed injection was administered. During the blinded phase of the trial, 194 participants randomized to CAB-LA experienced at least one injection delay. Plasma CAB concentrations were maintained above the 4× protein adjusted 90% inhibitory concentration (4× PA-IC CLINICAL TRIALS: This study is registered with ClinicalTrials.gov as NCT03164564.

Indexed as

Anti-HIV AgentsHIV InfectionsPyridonesAdultDelayed-Action PreparationsDiketopiperazinesDrug Administration ScheduleFemaleHumansMiddle AgedTenofovirAnti-HIV AgentscabotegravirDelayed-Action PreparationsDiketopiperazinesPyridonesTenofovircabotegravirHIVmodelingpharmacokineticsprevention

Identifiers

PMID39311597
PMCPMC11539227

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.