Evidence map›Paper›PMID 21732833›Full record

Trial reportThe New England journal of medicine2011

New regimens to prevent tuberculosis in adults with HIV infection.

Neil A Martinson, Grace L Barnes, Lawrence H Moulton, Reginah Msandiwa, Harry Hausler, Malathi Ram, James A McIntyre, Glenda E Gray, Richard E Chaisson

6 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 171 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
171citing papers in PubMed, 15 pooled it
17.2field-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.

NCT00057122 phase3completednot on this map

Novel TB Prevention Regimens for HIV-Infected Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2002 to 2009Enrolled1,148ConditionsHIV Infections, TuberculosisArmsIsoniazid, Rifapentine, Rifampin
NCT02771249 phase1completednot on this mapstarted 2016, after this paper: background citation

Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers

TypeinterventionalSponsorNational Institutes of Health Clinical Center (CC)Ran2016 to 2021Enrolled37ConditionsHIV Infected Population With Latent TuberculosisArmsrifapentene (RPT), darunavir/cobicistat (DRV/c), Isoniazid (INH), Pyridoxine
NCT02980016 phase3completednot on this mapstarted 2016, after this paper: background citation

A Randomised, Pragmatic, Open-Label Trial To Evaluate The Effect Of Three Months Of High Dose Rifapentine Plus Isoniazid Administered As A Single Round Or Given Annually In HIV-Positive Individuals

TypeinterventionalSponsorThe Aurum Institute NPCRan2016 to 2019Enrolled4,027ConditionsTuberculosis, HIVArmsrifapentine + isoniazid, Isoniazid
NCT03028129 phase4terminatednot on this mapstarted 2017, after this paper: background citation

Primary Prophylaxis for Prevention of TB in Prison's Populations

TypeinterventionalSponsorFederal University of Mato GrossoRan2017 to 2019Enrolled467ConditionsTuberculosis, Pulmonary, Antibiotic ProphylaxisArmsIsoniazid 900 milligrams, Placebo
NCT03302299 phase4completednot on this mapstarted 2017, after this paper: background citation

URBAN ARCH (3/5) Uganda Cohort TB Preventive Therapy for HIV-infected Alcohol Users in Uganda: an Evaluation of Safety Tolerability and Adherence

TypeinterventionalSponsorUniversity of California, San FranciscoRan2017 to 2021Enrolled302ConditionsTuberculosis, HIV/AIDS, Alcohol AbuseArmsIsoniazid 300 Mg ORAL TABLET, Pyridoxine 25 Mg Oral Tablet
NCT03934931 nacompletednot on this mapstarted 2020, after this paper: background citation

Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention: the 3HP Options Implementation Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2020 to 2025Enrolled1,656ConditionsTuberculosis, Latent Tuberculosis, HIV/AIDSArmsStreamlined weekly DOT visits, Weekly DOT visit reminders, Cost reimbursement DOT, 99DOTS, Weekly SAT dosing reminders/check-ins
3 · Its place in the literature

Who cites it

171 citing papers in PubMed, 15 syntheses or guidelines pooled it, 383 citations in OpenAlex.

  1. Pooled it
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  8. 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
  9. Pooled it
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  11. Rifampicin resistance after treatment for latent tuberculous infection: a systematic review and meta-analysis.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2016
    Pooled it
  12. Pooled it
  13. Guideline
  14. Pooled it
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  16. 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
  17. Trial
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  19. Implementing the 4R and 9H regimens for TB preventive treatment in Indonesia.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022
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  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Neil A MartinsonCenter for Tuberculosis Research and Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21231, USA.
Grace L Barnes
Lawrence H Moulton
Reginah Msandiwa
Harry Hausler
Malathi Ram
James A McIntyre
Glenda E Gray
Richard E Chaisson
Johns Hopkins University · USUniversity of the Witwatersrand · ZAUniversity of the Western Cape · ZA

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
TUBERCULOSIS INTERNATIONAL TRAINING AND RESEARCH PROGRAMD43TW000010 · FIC · JOHNS HOPKINS UNIVERSITY · PI BEYRER, CHRISTOPHER C. · 1988 to 2012
$19.8M
Novel TB Prevention Regimens for HIV-Infected AdultsR01AI048526 · NIAID · JOHNS HOPKINS UNIVERSITY · PI CHAISSON, RICHARD E. · 2001 to 2008
$5.5M
Research Infrastructure for the Hopkins Population CenterR24HD042854 · NICHD · JOHNS HOPKINS UNIVERSITY · PI CHERLIN, ANDREW J · 2003 to 2017
$5.1M
South Africa Tuberculosis AIDS Training (SATBAT)U2RTW007370 · FIC · WITS HEALTH CONSORTIUM (PTY), LTD · PI MARTINSON, NEIL A · 2007 to 2011
$1.9M
CLINICAL RESEARCH IN TUBERCULOSISK24AI001637 · NIAID · JOHNS HOPKINS UNIVERSITY · PI CHAISSON, RICHARD E. · 1999 to 2009
$1.3M
FIC NIH HHS D43 TW000010FIC NIH HHS D43 TW000010-21S1FIC NIH HHS U2R TW007370NIAID NIH HHS AI01637NIAID NIH HHS AI048526NIAID NIH HHS K24 AI001637NIAID NIH HHS P30 AI094189NIAID NIH HHS R01 AI048526NICHD NIH HHS R24 HD042854PHS HHS 5U2RTW007370
6 · The paper itself

Abstract

backgroundTreatment of latent tuberculosis in patients infected with the human immunodeficiency virus (HIV) is efficacious, but few patients around the world receive such treatment. We evaluated three new regimens for latent tuberculosis that may be more potent and durable than standard isoniazid treatment.

methodsWe randomly assigned South African adults with HIV infection and a positive tuberculin skin test who were not taking antiretroviral therapy to receive rifapentine (900 mg) plus isoniazid (900 mg) weekly for 12 weeks, rifampin (600 mg) plus isoniazid (900 mg) twice weekly for 12 weeks, isoniazid (300 mg) daily for up to 6 years (continuous isoniazid), or isoniazid (300 mg) daily for 6 months (control group). The primary end point was tuberculosis-free survival.

resultsThe 1148 patients had a median age of 30 years and a median CD4 cell count of 484 per cubic millimeter. Incidence rates of active tuberculosis or death were 3.1 per 100 person-years in the rifapentine-isoniazid group, 2.9 per 100 person-years in the rifampin-isoniazid group, and 2.7 per 100 person-years in the continuous-isoniazid group, as compared with 3.6 per 100 person-years in the control group (P>0.05 for all comparisons). Serious adverse reactions were more common in the continuous-isoniazid group (18.4 per 100 person-years) than in the other treatment groups (8.7 to 15.4 per 100 person-years). Two of 58 isolates of Mycobacterium tuberculosis (3.4%) were found to have multidrug resistance.

conclusionsOn the basis of the expected rates of tuberculosis in this population of HIV-infected adults, all secondary prophylactic regimens were effective. Neither a 3-month course of intermittent rifapentine or rifampin with isoniazid nor continuous isoniazid was superior to 6 months of isoniazid. (Funded by the National Institute of Allergy and Infectious Diseases and others; ClinicalTrials.gov number, NCT00057122.).

Indexed as

AdultAIDS-Related Opportunistic InfectionsAnti-Retroviral AgentsAntitubercular AgentsCause of DeathDrug Administration ScheduleDrug Resistance, BacterialDrug Therapy, CombinationFemaleFollow-Up StudiesHIV InfectionsHumansIsoniazidKaplan-Meier EstimateMaleMycobacterium tuberculosisAnti-Retroviral AgentsAntitubercular AgentsIsoniazidRifampinrifapentine

Identifiers

PMID21732833
PMCPMC3407678
OpenAlexW2166112014

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.