Generated Narrative: Citation 153881

url: Citation Delany-Moretlwe 2022 clinical trial

identifier: FEvIR Object Identifier/153881, https://pubmed.ncbi.nlm.nih.gov/35378077, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.26

version: 2.0.0-ballot

title: Delany-Moretlwe 2022 clinical trial

status: Active

date: 2024-11-21 14:09:14+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

description:

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jurisdiction: World

copyright:

approvalDate: 2022-05-10

lastReviewDate: 2023-03-17

author: Brian S. Alper: , Computable Publishing®: MEDLINE-to-FEvIR Converter:

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classifier: MEDLINE

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classifier: National Library of Medicine, Index Section

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period: ?? --> 2022-02-27

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activity: PubMed Pubstatus of Revised

period: ?? --> 2022-03-12

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activity: PubMed Pubstatus of Accepted

period: ?? --> 2022-03-14

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activity: PubMed Pubstatus of Pubmed

period: ?? --> 2022-04-05 06:00:00+0000

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period: ?? --> 2022-05-11 06:00:00+0000

statusDate

activity: PubMed Pubstatus of Entrez

period: ?? --> 2022-04-04 20:10:00+0000

citedArtifact

identifier: https://pubmed.ncbi.nlm.nih.gov/35378077, https://www.ncbi.nlm.nih.gov/pmc//PMC9077443, https://doi.org/10.1016/S0140-6736(22)00538-4, pii/S0140-6736(22)00538-4

relatedIdentifier: https://clinicaltrials.gov/NCT03164564

Titles

-	Type	Language	Text
*	Primary title	English	Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial.

Abstracts

-	Text	Copyright
*	BACKGROUND: Oral pre-exposure prophylaxis has been introduced in more than 70 countries, including many in sub-Saharan Africa, but women experience considerable barriers to daily pill-taking, such as stigma, judgement, and the fear of violence. Safe and effective long-acting agents for HIV prevention are needed for women. We aimed to evaluate the safety and efficacy of injectable cabotegravir compared with daily oral tenofovir diphosphate plus emtricitabine (TDF-FTC) for HIV prevention in HIV-uninfected women. METHODS: HPTN 084 was a phase 3, randomised, double-blind, double-dummy, active-controlled, superiority trial in 20 clinical research sites in seven countries in sub-Saharan Africa. Participants were eligible for enrolment if they were assigned female sex at birth, were aged 18-45 years, reported at least two episodes of vaginal intercourse in the previous 30 days, were at risk of HIV infection based on an HIV risk score, and agreed to use a long-acting reversible contraceptive method. Participants were randomly assigned (1:1) to either active cabotegravir with TDF-FTC placebo (cabotegravir group) or active TDF-FTC with cabotegravir placebo (TDF-FTC group). Study staff and participants were masked to study group allocation, with the exception of the site pharmacist who was responsible for study product preparation. Participants were prescribed 5 weeks of daily oral product followed by intramuscular injections every 8 weeks after an initial 4-week interval load, alongside daily oral pills. Participants who discontinued injections were offered open-label daily TDF-FTC for 48 weeks. The primary endpoints of the study were incident HIV infection in the intention-to-treat population, and clinical and laboratory events that were grade 2 or higher in all women who had received at least one dose of study product. This study is registered with ClinicalTrials.gov, NCT03164564. FINDINGS: From Nov 27, 2017, to Nov 4, 2020, we enrolled 3224 participants (1614 in the cabotegravir group and 1610 in the TDF-FTC group). Median age was 25 years (IQR 22-30); 1755 (54·7%) of 3209 had two or more partners in the preceding month. 40 incident infections were observed over 3898 person-years (HIV incidence 1·0% [95% CI 0·73-1·40]); four in the cabotegravir group (HIV incidence 0·2 cases per 100 person-years [0·06-0·52]) and 36 in the TDF-FTC group (1·85 cases per 100 person-years [1·3-2·57]; hazard ratio 0·12 [0·05-0·31]; p<0·0001; risk difference -1·6% [-1·0% to -2·3%]. In a random subset of 405 TDF-FTC participants, 812 (42·1%) of 1929 plasma samples had tenofovir concentrations consistent with daily use. Injection coverage was 93% of the total number of person-years. Adverse event rates were similar across both groups, apart from injection site reactions, which were more frequent in the cabotegravir group than in the TDF-FTC group (577 [38·0%] of 1519 vs 162 [10·7%] of 1516]) but did not result in injection discontinuation. Confirmed pregnancy incidence was 1·3 per 100 person-years (0·9-1·7); no congenital birth anomalies were reported. INTERPRETATION: Although both products for HIV prevention were generally safe, well tolerated, and effective, cabotegravir was superior to TDF-FTC in preventing HIV infection in women. FUNDING: National Institute of Allergy and Infectious Diseases, ViiV Healthcare, and the Bill & Melinda Gates Foundation. Additional support was provided through the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. ViiV Healthcare and Gilead Sciences provided pharmaceutical support.	Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

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identifier: Electronic ISSN Type/1474-547X, ISOAbbreviation/Lancet, ISSN Linking/0140-6736, Medline Title Abbreviation/Lancet, NLM Unique ID/2985213R

title: Lancet (London, England)

publisherLocation: England

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issue: 10337

articleDate: 2022-05-07

publicationDateText: 2022-May-07

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type: Publishing Model

classifier: Print Electronic

classification

type: Chemical

classifier: Anti-HIV Agents, Diketopiperazines, Pyridones, Emtricitabine, cabotegravir

classification

type: MeSH Heading

artifactAssessment: ArtifactAssessment: artifact[x] = this resource

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type: Publication Type

classifier: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial

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artifactAssessment: Classifier added by Computable Publishing LLC

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contributorship

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entry

contributor: Delany-Moretlwe S

forenameInitials: S

affiliation: Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: sdelany@wrhi.ac.za.

entry

contributor: Hughes JP

forenameInitials: JP

affiliation: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

entry

contributor: Bock P

forenameInitials: P

affiliation: Desmond Tutu TB Centre, University of Stellenbosch, Stellenbosch, South Africa.

entry

contributor: Ouma SG

forenameInitials: SG

affiliation: Kisumu Clinical Research Site, Centre for Global Health Research, Kenya Medical Research Institute, Kisumu, Kenya.

entry

contributor: Hunidzarira P

forenameInitials: P

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Kalonji D

forenameInitials: D

affiliation: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.

entry

contributor: Kayange N

forenameInitials: N

affiliation: Blantyre Clinical Research Site, College of Medicine, University of Malawi, Blantyre, Malawi.

entry

contributor: Makhema J

forenameInitials: J

affiliation: Botswana Harvard AIDS Institute Partnership (BHP), Gaborone, Botswana.

entry

contributor: Mandima P

forenameInitials: P

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Mathew C

forenameInitials: C

affiliation: Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.

entry

contributor: Spooner E

forenameInitials: E

affiliation: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.

entry

contributor: Mpendo J

forenameInitials: J

affiliation: International AIDS Vaccine Initiative, Uganda Virus Research Institute, Entebbe, Uganda.

entry

contributor: Mukwekwerere P

forenameInitials: P

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Mgodi N

forenameInitials: N

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Ntege PN

forenameInitials: PN

affiliation: Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.

entry

contributor: Nair G

forenameInitials: G

affiliation: Desmond Tutu Health Foundation, University of Cape Town, Cape Town, South Africa.

entry

contributor: Nakabiito C

forenameInitials: C

affiliation: Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.

entry

contributor: Nuwagaba-Biribonwoha H

forenameInitials: H

affiliation: Eswatini Prevention Center, International Center for AIDS Care and Treatment Program at Columbia University Mailman School of Public Health, New York, NY, USA.

entry

contributor: Panchia R

forenameInitials: R

affiliation: Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.

entry

contributor: Singh N

forenameInitials: N

affiliation: HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa.

entry

contributor: Siziba B

forenameInitials: B

affiliation: Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.

entry

contributor: Farrior J

forenameInitials: J

affiliation: FHI 360, Durham, NC, USA.

entry

contributor: Rose S

forenameInitials: S

affiliation: FHI 360, Durham, NC, USA.

entry

contributor: Anderson PL

forenameInitials: PL

affiliation: Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.

entry

contributor: Eshleman SH

forenameInitials: SH

affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

entry

contributor: Marzinke MA

forenameInitials: MA

affiliation: Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

entry

contributor: Hendrix CW

forenameInitials: CW

affiliation: Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

entry

contributor: Beigel-Orme S

forenameInitials: S

affiliation: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

entry

contributor: Hosek S

forenameInitials: S

affiliation: Department of Psychiatry, Stroger Hospital of Cook County, Chicago, IL, USA.

entry

contributor: Tolley E

forenameInitials: E

affiliation: FHI 360, Durham, NC, USA.

entry

contributor: Sista N

forenameInitials: N

affiliation: FHI 360, Durham, NC, USA.

entry

contributor: Adeyeye A

forenameInitials: A

affiliation: Division of AIDS, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.

entry

contributor: Rooney JF

forenameInitials: JF

affiliation: Gilead Sciences, Foster City, CA, USA.

entry

contributor: Rinehart A

forenameInitials: A

affiliation: ViiV Healthcare, Durham, NC, USA.

entry

contributor: Spreen WR

forenameInitials: WR

affiliation: ViiV Healthcare, Durham, NC, USA.

entry

contributor: Smith K

forenameInitials: K

affiliation: ViiV Healthcare, Durham, NC, USA.

entry

contributor: Hanscom B

forenameInitials: B

affiliation: Statistical Centre for HIV/AIDS Research and Prevention, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

entry

contributor: Cohen MS

forenameInitials: MS

affiliation: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA.

entry

contributor: Hosseinipour MC

forenameInitials: MC

affiliation: University of North Carolina (UNC) at Chapel Hill, Chapel Hill, NC, USA; UNC Project-Malawi, Lilongwe, Malawi.

entry

contributor: HPTN 084 study group

Generated Narrative: Practitioner #author0

name: Sinead Delany-Moretlwe

Generated Narrative: Practitioner #author1

name: James P Hughes

Generated Narrative: Practitioner #author2

name: Peter Bock

Generated Narrative: Practitioner #author3

name: Samuel Gurrion Ouma

Generated Narrative: Practitioner #author4

name: Portia Hunidzarira

Generated Narrative: Practitioner #author5

name: Dishiki Kalonji

Generated Narrative: Practitioner #author6

name: Noel Kayange

Generated Narrative: Practitioner #author7

name: Joseph Makhema

Generated Narrative: Practitioner #author8

name: Patricia Mandima

Generated Narrative: Practitioner #author9

name: Carrie Mathew

Generated Narrative: Practitioner #author10

name: Elizabeth Spooner

Generated Narrative: Practitioner #author11

name: Juliet Mpendo

Generated Narrative: Practitioner #author12

name: Pamela Mukwekwerere

Generated Narrative: Practitioner #author13

name: Nyaradzo Mgodi

Generated Narrative: Practitioner #author14

name: Patricia Nahirya Ntege

Generated Narrative: Practitioner #author15

name: Gonasagrie Nair

Generated Narrative: Practitioner #author16

name: Clemensia Nakabiito

Generated Narrative: Practitioner #author17

name: Harriet Nuwagaba-Biribonwoha

Generated Narrative: Practitioner #author18

name: Ravindre Panchia

Generated Narrative: Practitioner #author19

name: Nishanta Singh

Generated Narrative: Practitioner #author20

name: Bekezela Siziba

Generated Narrative: Practitioner #author21

name: Jennifer Farrior

Generated Narrative: Practitioner #author22

name: Scott Rose

Generated Narrative: Practitioner #author23

name: Peter L Anderson

Generated Narrative: Practitioner #author24

name: Susan H Eshleman

Generated Narrative: Practitioner #author25

name: Mark A Marzinke

Generated Narrative: Practitioner #author26

name: Craig W Hendrix

Generated Narrative: Practitioner #author27

name: Stephanie Beigel-Orme

Generated Narrative: Practitioner #author28

name: Sybil Hosek

Generated Narrative: Practitioner #author29

name: Elizabeth Tolley

Generated Narrative: Practitioner #author30

name: Nirupama Sista

Generated Narrative: Practitioner #author31

name: Adeola Adeyeye

Generated Narrative: Practitioner #author32

name: James F Rooney

Generated Narrative: Practitioner #author33

name: Alex Rinehart

Generated Narrative: Practitioner #author34

name: William R Spreen

Generated Narrative: Practitioner #author35

name: Kimberly Smith

Generated Narrative: Practitioner #author36

name: Brett Hanscom

Generated Narrative: Practitioner #author37

name: Myron S Cohen

Generated Narrative: Practitioner #author38

name: Mina C Hosseinipour

Generated Narrative: Organization #author39

name: HPTN 084 study group

Generated Narrative: ArtifactAssessment #meshHeading0

artifact: Citation Delany-Moretlwe 2022 clinical trial

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Adult

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Anti-HIV Agents

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is Major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Child

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Diketopiperazines

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Emtricitabine

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: therapeutic use

Components

-	Type	Classifier
*	is Major topic	No

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: Female

freeToShare: true

Components

-	Type	Classifier
*	qualifier	is not a major topic

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: HIV Infections

freeToShare: true

component

type: qualifier

classifier: is Major topic

component

type: qualifier

classifier: chemically induced

Components

-	Type	Classifier
*	is Major topic	No

component

type: qualifier

classifier: epidemiology

Components

-	Type	Classifier
*	is Major topic	No

component

type: qualifier

classifier: prevention & control

Components

-	Type	Classifier
*	is Major topic	No

content

informationType: Classifier

type: components (if present) include qualifier codings

classifier: HIV Seropositivity

freeToShare: true

component

type: qualifier

classifier: is Major topic

component

type: qualifier

classifier: drug therapy

Components

-	Type	Classifier
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type: components (if present) include qualifier codings

classifier: HIV-1

freeToShare: true

Components

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type: components (if present) include qualifier codings

classifier: Humans

freeToShare: true

Components

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type: components (if present) include qualifier codings

classifier: Infant, Newborn

freeToShare: true

Components

-	Type	Classifier
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type: components (if present) include qualifier codings

classifier: Pregnancy

freeToShare: true

Components

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type: components (if present) include qualifier codings

classifier: Pyridones

freeToShare: true

component

type: qualifier

classifier: is not a major topic

component

type: qualifier

classifier: therapeutic use

Components

-	Type	Classifier
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