Evidence map›Paper›PMID 36041016›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Rifapentine With and Without Moxifloxacin for Pulmonary Tuberculosis in People With Human Immunodeficiency Virus (S31/A5349).

April C Pettit, Patrick P J Phillips, Ekaterina Kurbatova, Andrew Vernon, Payam Nahid, Rodney Dawson, Kelly E Dooley, Ian Sanne, Ziyaad Waja, Lerato Mohapi and 13 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase IIIEquivalence 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, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02410772 (Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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.

NCT02410772 phase3completednot on this map

Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2016 to 2021Enrolled2,516ConditionsTuberculosisArmsrifapentine, rifapentine and moxifloxacin, control
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Guideline
  2. New drugs for the management of tuberculosis.Current opinion in infectious diseases · 2025
    Review
  3. Review
  4. The miRNomics of antiretroviral therapy-induced obesity.Functional & integrative genomics · 2025
    Review
  5. Article
  6. Article
  7. 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

23 authors at 12 institutions in 4 countries.

April C PettitDepartment of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID 0000-0001-8832-0866
Patrick P J PhillipsUCSF Center for Tuberculosis, University of California San Francisco, San Francisco, California, USA.
Ekaterina KurbatovaDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Andrew VernonDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Payam NahidUCSF Center for Tuberculosis, University of California San Francisco, San Francisco, California, USA.
Rodney DawsonCenter for TB Research Innovation, University of Cape Town Lung Institute, Cape Town, South Africa.
Kelly E DooleyDepartment of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Ian SanneClinical HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.
Ziyaad WajaPerinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
Lerato MohapiPerinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
Anthony T PodanyDepartment of Pharmacy Practice and Science, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Wadzanai SamanekaDepartment of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.
Rada M SavicUCSF Center for Tuberculosis, University of California San Francisco, San Francisco, California, USA.
John L JohnsonTuberculosis Research Unit, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Grace MuzanyiUganda-Case Western Reserve University Research Collaboration, Kampala, Uganda.
Umesh G LallooEnhancing Care Foundation, Durban University of Technology, Durban, South Africa.
Kia BryantDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Erin SizemoreDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Nigel ScottDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Susan E DormanDepartment of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.
Richard E ChaissonDepartment of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Susan SwindellsDepartment of Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA.
Tuberculosis Trials Consortium (TBTC) Study 31/AIDS Clinical Trials Group (ACTG) A5349 study team
Centers for Disease Control and Prevention · USUniversity of California, San Francisco · USUniversity of the Witwatersrand · ZAJohns Hopkins University · USUniversity of Nebraska Medical Center · USDurban University of Technology · ZAMedical University of South Carolina · USMUJHU Research Collaboration · UGUniversity Hospitals of Cleveland · USUniversity of Cape Town · ZAUniversity of Zimbabwe · ZWVanderbilt University Medical Center · US

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
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
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
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
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitU01AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BENSON, CONSTANCE ANN · 2007 to 2011
$19.3M
NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069436NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundTuberculosis (TB) Trials Consortium Study 31/AIDS Clinical Trials Group A5349, an international randomized open-label phase 3 noninferiority trial showed that a 4-month daily regimen substituting rifapentine for rifampin and moxifloxacin for ethambutol had noninferior efficacy and was safe for the treatment of drug-susceptible pulmonary TB (DS-PTB) compared with the standard 6-month regimen. We explored results among the prespecified subgroup of people with human immunodeficiency virus (HIV) (PWH).

methodsPWH and CD4+ counts ≥100 cells/μL were eligible if they were receiving or about to initiate efavirenz-based antiretroviral therapy (ART). Primary endpoints of TB disease-free survival 12 months after randomization (efficacy) and ≥ grade 3 adverse events (AEs) on treatment (safety) were compared, using a 6.6% noninferiority margin for efficacy. Randomization was stratified by site, pulmonary cavitation, and HIV status. PWH were enrolled in a staged fashion to support cautious evaluation of drug-drug interactions between rifapentine and efavirenz.

resultsA total of 2516 participants from 13 countries in sub-Saharan Africa, Asia, and the Americas were enrolled. Among 194 (8%) microbiologically eligible PWH, the median CD4+ count was 344 cells/μL (interquartile range: 223-455). The rifapentine-moxifloxacin regimen was noninferior to control (absolute difference in unfavorable outcomes -7.4%; 95% confidence interval [CI] -20.8% to 6.0%); the rifapentine regimen was not noninferior to control (+7.5% [95% CI, -7.3% to +22.4%]). Fewer AEs were reported in rifapentine-based regimens (15%) than the control regimen (21%).

conclusionsIn people with HIV-associated DS-PTB with CD4+ counts ≥100 cells/μL on efavirenz-based ART, the 4-month daily rifapentine-moxifloxacin regimen was noninferior to the 6-month control regimen and was safe. CLINICAL TRIALS REGISTRATION: NCT02410772.

Indexed as

HIV InfectionsTuberculosisTuberculosis, PulmonaryAlkynesAntitubercular AgentsBenzoxazinesCyclopropanesDrug Therapy, CombinationHIVHumansIsoniazidMoxifloxacinRifampinAlkynesAntitubercular AgentsBenzoxazinesCyclopropanesefavirenzIsoniazidMoxifloxacinRifampinrifapentinehuman immunodeficiency virusmoxifloxacinphase 3 clinical trialrifapentinetuberculosis

Identifiers

PMID36041016
PMCPMC10169427
OpenAlexW4293701559

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.