Evidence map›Paper›PMID 27243774›Full record

Trial reportAIDS (London, England)2016

Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons.

Timothy R Sterling, Nigel A Scott, Jose M Miro, Guilherme Calvet, Alberto La Rosa, Rosa Infante, Michael P Chen, Debra A Benator, Fred Gordin, Constance A Benson and 3 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03783728 (Efficacy of Risk-Targeted Video Based Directly on Observed Therapy for Latent TB), which is not on this map. Cited by 90 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing papers in PubMed, 10 pooled it
12.5field-weighted citation impact, top 1% 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.

NCT03783728 withdrawnnot on this mapstarted 2019, after this paper: background citation

Efficacy of Risk-Targeted Video Based Directly on Observed Therapy for Latent TB

TypeobservationalSponsorSt. Louis UniversityRan2019 to 2020Enrolled0ConditionsLatent TuberculosisArmsRifapentine 600 mg orally, Isoniazid 900 mg orally, Pyridoxine 50 mg orally
3 · Its place in the literature

Who cites it

90 citing papers in PubMed, 10 syntheses or guidelines pooled it, 162 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guidelines for the Treatment of Latent Tuberculosis Infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
    Pooled it
  7. Pooled it
  8. Guideline
  9. Pooled it
  10. Guideline
  11. Three Months of Weekly Rifapentine and Isoniazid Versus Four Months of Daily Rifampicin for Tuberculosis Infection: A Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Trial
  12. Trial
  13. Twice-Daily Dolutegravir-Based Antiretroviral Therapy With 1 Month of Daily Rifapentine and Isoniazid for Tuberculosis Prevention.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Cytokine-Mediated Systemic Adverse Drug Reactions in a Drug-Drug Interaction Study of Dolutegravir With Once-Weekly Isoniazid and Rifapentine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Trial
  19. Article
  20. Article

30 more citing papers are in PubMed but not listed here.

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

13 authors at 9 institutions in 4 countries.

Timothy R SterlingaVanderbilt University School of Medicine, Nashville, Tennessee bCenters for Disease Control and Prevention, Atlanta, Georgia, USA cHospital Clinic - IDIBAPS, University of Barcelona, Barcelona, Spain dInstituto Nacional de Infectologia, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil eAsociacion Civil Impacta Salud y Educacion, Lima, Peru fVeterans Affairs Medical Center gGeorge Washington University, Washington, District of Columbia hUniversity of California at San Diego, California iJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Nigel A Scott
Jose M Miro
Guilherme Calvet
Alberto La Rosa
Rosa Infante
Michael P Chen
Debra A Benator
Fred Gordin
Constance A Benson
Richard E Chaisson
M Elsa Villarino
Tuberculosis Trials Consortium, the AIDS Clinical Trials Group for the PREVENT TB Trial (TBTC Study 26ACTG 5259) The investigators of the TB Trials Consortium and the AIDS Clinical Trials Group for the PREVENT TB Trial are listed in the Supplement, item 17
Centers for Disease Control and Prevention · USAsociación Civil Impacta Salud y Educación · PEConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESFundação Oswaldo Cruz · BRGeorge Washington University · USJohns Hopkins Medicine · USUniversity of California, San Diego · USVanderbilt University · USVeterans Health Administration · 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
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Mentoring in HIV and Tuberculosis ResearchK24AI065298 · NIAID · VANDERBILT UNIVERSITY · PI STERLING, TIMOTHY R · 2005 to 2014
$1.6M
NIAID NIH HHS K24 AI065298NIAID NIH HHS P30 AI094189NIAID NIH HHS UM1 AI068634
6 · The paper itself

Abstract

objectiveCompare the effectiveness, tolerability, and safety of 3 months of weekly rifapentine and isoniazid under direct observation (3HP) versus 9 months of daily isoniazid (9H) in HIV-infected persons.

designProspective, randomized, and open-label noninferiority trial.

settingThe United States , Brazil, Spain, Peru, Canada, and Hong Kong.

participantsHIV-infected persons who were tuberculin skin test positive or close contacts of tuberculosis cases.

intervention3HP versus 9H.

main outcome measuresThe effectiveness endpoint was tuberculosis; the noninferiority margin was 0.75%. The tolerability endpoint was treatment completion; the safety endpoint was drug discontinuation because of adverse drug reaction.

resultsMedian baseline CD4 cell counts were 495 (IQR 389-675) and 538 (IQR 418-729) cells/μl in the 3HP and 9H arms, respectively (P = 0.09). In the modified intention-to-treat analysis, there were two tuberculosis cases among 206 persons [517 person-years (p-y) of follow-up] in the 3HP arm (0.39 per 100 p-y) and six tuberculosis cases among 193 persons (481 p-y of follow-up) in the 9H arm (1.25 per 100 p-y). Cumulative tuberculosis rates were 1.01 versus 3.50% in the 3HP and 9H arms, respectively (rate difference: -2.49%; upper bound of the 95% confidence interval of the difference: 0.60%). Treatment completion was higher with 3HP (89%) than 9H (64%) (P < 0.001), and drug discontinuation because of an adverse drug reaction was similar (3 vs. 4%; P = 0.79) in 3HP and 9H, respectively.

conclusionAmong HIV-infected persons with median CD4 cell count of approximately 500 cells/μl, 3HP was as effective and safe for treatment of latent Mycobacterium tuberculosis infection as 9H, and better tolerated.

Indexed as

AdolescentAdultAmericasAntitubercular AgentsAsiaChildDrug-Related Side Effects and Adverse ReactionsFemaleHIV InfectionsHumansIsoniazidMaleProspective StudiesRifampinTreatment OutcomeTuberculosisAntitubercular AgentsIsoniazidRifampinrifapentine

Identifiers

PMID27243774
PMCPMC4899978
OpenAlexW2465612624

What OpenQuestion holds

Textmetadata
LicenceTDM
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.