Evidence map›Paper›PMID 32452972›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2020

Brief Report: Hormonal Contraception Use and Cabotegravir Pharmacokinetics in HIV-Uninfected Women Enrolled in HPTN 077.

Cheríe S Blair, Sue Li, Gordon Chau, Leslie Cottle, Paul Richardson, Mark A Marzinke, Susan H Eshleman, Adeola Adeyeye, Alex R Rinehart, David Margolis and 4 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.2field-weighted citation impact, top 33% 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

10 citing papers in PubMed, 16 citations in OpenAlex.

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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

14 authors at 5 institutions in 1 country.

Cheríe S BlairUCLA Center for Clinical AIDS Research & Education, Los Angeles, CA.
Sue LiStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA.
Gordon ChauStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA.
Leslie CottleStatistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA.
Paul RichardsonDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.
Mark A MarzinkeDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.
Susan H EshlemanDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.
Adeola AdeyeyeDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD.
Alex R RinehartViiV Healthcare, Durham, NC; and.
David MargolisViiV Healthcare, Durham, NC; and.
Marybeth McCauleyFHI360, Durham, NC.
Craig W HendrixDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.
Raphael J LandovitzUCLA Center for Clinical AIDS Research & Education, Los Angeles, CA.
HPTN 077 Study Team
Johns Hopkins University · USFred Hutch Cancer Center · USAPLA Health · USFamily Health International 360 · USNational Institutes of Health · US

Funding

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
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
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
Postdoctoral Training in Global AIDS Prevention ResearchT32MH080634 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI JESSE LAWTON CLARK, Pamina Mae Gorbach · 2007 to 2026
$6.4M
NIAID NIH HHS L30 AI147119NIAID NIH HHS P30 AI094189NIAID NIH HHS UM1 AI068613NIAID NIH HHS UM1 AI068617NIAID NIH HHS UM1 AI068619NIAID NIH HHS UM1 AI069424NIMH NIH HHS T32 MH080634
6 · The paper itself

Abstract

objectivesTo evaluate whether hormonal contraceptive use among cisgender women is associated with differences in pharmacokinetic (PK) parameters of a long-acting injectable formulation of the integrase strand transfer inhibitor, cabotegravir (CAB-LA).

settingThis is a secondary analysis of 85 cisgender women enrolled in HPTN 077, a phase 2a multicenter study that enrolled HIV-uninfected, low-risk individuals in Malawi, Brazil, South Africa, and the United States.

methodsParticipants received 4-week daily oral cabotegravir lead-in, followed by CAB-LA 800 mg injection every 12 weeks (cohort 1) or 600 mg every 8 weeks (after 4-week initial interval between injections, cohort 2), over 41 weeks. Participants were followed 52-76 weeks subsequent to final injection. Generalized estimating equations and linear regression were used to evaluate differences in CAB-LA PK parameters (peak concentration, trough concentration, area under the curve, apparent terminal half-life, and time to lower limit of quantification) and self-reported hormonal contraceptive stratified by type (oral, injectable, implants, and other), controlling for body mass index and cohort.

resultsCompared to women reporting no hormonal contraception (n = 6), oral contraceptive use (n = 18) was associated with lower CAB-LA peak concentration but was not associated with differences in other PK parameters. No other hormonal contraceptive type (injectable, implants, and other) was associated with significant differences in CAB-LA PK parameters.

conclusionAlthough oral contraceptive use was associated with differences in CAB-LA peak concentration, no differences were observed in other PK parameters, suggesting that this association is not likely to be clinically significant. However, these data highlight the need for further research exploring potential drug-drug interactions between CAB-LA and hormonal contraceptives.

Indexed as

Contraceptive Agents, FemaleHIV-1HIV InfectionsHIV Integrase InhibitorsPyridonesBrazilDiketopiperazinesDrug InteractionsFemaleHIV SeronegativityHormonal ContraceptionHumansMalawiPre-Exposure ProphylaxisSouth AfricaYoung AdultcabotegravirContraceptive Agents, FemaleDiketopiperazinesHIV Integrase InhibitorsPyridones

Identifiers

PMID32452972
PMCPMC7549535
OpenAlexW3032270462

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.