Evidence map›Paper›PMID 38568956›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Twice-Daily Dolutegravir-Based Antiretroviral Therapy With 1 Month of Daily Rifapentine and Isoniazid for Tuberculosis Prevention.

Anthony T Podany, Yoninah Cramer, Marjorie Imperial, Susan L Rosenkranz, Anchalee Avihingsanon, Roberto Arduino, Wadzanai Samaneka, Irina Gelmanova, Rada Savic, Susan Swindells and 2 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyClinical Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04272242 (Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.9field-weighted citation impact, top 15% 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.

NCT04272242 phase2terminatednot on this map

Drug-Drug Interactions Between Rifapentine and Dolutegravir in HIV/LTBI Co-Infected Individuals

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2021 to 2021Enrolled37ConditionsHIV Infection, LTBIArmsDolutegravir (DTG), Isoniazid (INH), Rifapentine (RPT), Antiretroviral Therapy (ART), Pyridoxine (Vitamin B6)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
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  7. Article
  8. Review
  9. 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 8 institutions in 4 countries.

Anthony T PodanyCollege of Pharmacy, University of Nebraska Medical Center, Omaha.ORCID 0000-0002-8371-0379
Yoninah CramerStatistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts.
Marjorie ImperialCollege of Pharmacy, University of California, San Francisco.
Susan L RosenkranzStatistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts.
Anchalee AvihingsanonThai Red Cross AIDS Research Center and Center of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Roberto ArduinoMcGovern Medical School, University of Texas Health Science Center at Houston, Texas.
Wadzanai SamanekaCollege of Health Sciences, University of Zimbabwe, Harare.
Irina GelmanovaDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
Rada SavicCollege of Pharmacy, University of California, San Francisco.
Susan SwindellsInfectious Diseases, Internal Medicine, University of Nebraska Medical Center, Omaha.ORCID 0000-0001-5826-6037
Rodney DawsonLung Institute, University of Cape Town, South Africa.
Anne F LuetkemeyerCollege of Medicine, University of California, San Francisco.
University of California, San Francisco · USHarvard University · USUniversity of Nebraska Medical Center · USChulalongkorn University · THNational Institute of Allergy and Infectious Diseases · USThe University of Texas Health Science Center · USUniversity of Cape Town · ZAUniversity of Zimbabwe · ZW

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
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
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
Clinical Pharmacology of Efavirenz Combined with High Dose RifapentineK23AI134307 · NIAID · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI PODANY, ANTHONY T · 2018 to 2022
$819k
National Institute of Allergy and Infectious DiseasesNIAID NIH HHS K23 AI134307NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI106701NIH HHS AI068634
6 · The paper itself

Abstract

backgroundOne month of daily rifapentine + isoniazid (1HP) is an effective, ultrashort option for tuberculosis prevention in people with human immunodeficiency virus (HIV). However, rifapentine may decrease antiretroviral drug concentrations and increase the risk of virologic failure. AIDS Clinical Trials Group A5372 evaluated the effect of 1HP on the pharmacokinetics of twice-daily dolutegravir.

methodsA5372 was a multicenter, pharmacokinetic study in people with HIV (≥18 years) already on dolutegravir-containing antiretroviral therapy with HIV RNA <50 copies/mL. Participants received daily rifapentine/isoniazid (600 mg/300 mg) for 28 days as part of 1HP. Dolutegravir was increased to 50 mg twice daily during 1HP, and intensive pharmacokinetic sampling was performed on day 0 (before 1HP) and on the final day of 1HP treatment.

resultsThirty-two participants (41% female; 66% Black/African; median [Q1, Q3] age, 42 [34, 49] years) were included in the pharmacokinetic analysis; 31 had HIV RNA <50 copies/mL at the end of 1HP dosing. One participant had an HIV RNA of 160 copies/mL at day 28, with HIV RNA <50 copies/mL upon repeat testing on day 42. The median (Q1, Q3) dolutegravir trough concentration was 1751 ng/mL (1195, 2542) on day 0 versus 1987 ng/mL (1331, 2278) on day 28 (day 28:day 0 geometric mean ratio, 1.05 [90% confidence interval, .93-1.2]; P = .43). No serious adverse events were reported.

conclusionsDolutegravir trough concentrations with 50 mg twice-daily dosing during 1HP treatment were greater than those with standard-dose dolutegravir once daily without 1HP. These pharmacokinetic, virologic, and safety data provide support for twice-daily dolutegravir use in combination with 1HP for tuberculosis prevention. CLINICAL TRIALS REGISTRATION: NCT04272242.

Indexed as

Heterocyclic Compounds, 3-RingHIV InfectionsIsoniazidOxazinesPiperazinesPyridonesRifampinTuberculosisAdultAnti-HIV AgentsAntitubercular AgentsDolutegravirDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansAnti-HIV AgentsAntitubercular AgentsDolutegravirHeterocyclic Compounds, 3-RingIsoniazidOxazinesPiperazinesPyridonesRifampinrifapentineHIV/AIDSpharmacodynamicspharmacokineticsrifapentinetuberculosis

Identifiers

PMID38568956
PMCPMC11478809
OpenAlexW4393853029

What Socratic 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 Socratic graph.