Evidence map›Paper›PMID 31412895›Full record

Trial reportBMC pulmonary medicine2019

Toxicity related to standard TB therapy for pulmonary tuberculosis and treatment outcomes in the REMoxTB study according to HIV status.

Conor D Tweed, Angela M Crook, Rodney Dawson, Andreas H Diacon, Timothy D McHugh, Carl M Mendel, Sarah K Meredith, Lerato Mohapi, Michael E Murphy, Andrew J Nunn and 4 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pulmonary medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

Conor D TweedMRC Clinical Trials Unit at University College London, London, UK. c.tweed@ucl.ac.uk.ORCID http://orcid.org/0000-0001-6021-8237
Angela M CrookMRC Clinical Trials Unit at University College London, London, UK.
Rodney DawsonUniversity of Cape Town Lung Institute, Cape Town, South Africa.
Andreas H DiaconTASK Applied Science, Cape Town, South Africa.
Timothy D McHughDivision of Infection and Immunity, University College London, London, UK.
Carl M MendelTB Alliance, New York, USA.
Sarah K MeredithMRC Clinical Trials Unit at University College London, London, UK.
Lerato MohapiPerinatal HIV Research Unit, Johannesburg, South Africa.
Michael E MurphyDivision of Infection and Immunity, University College London, London, UK.
Andrew J NunnMRC Clinical Trials Unit at University College London, London, UK.
Patrick P J PhillipsDivision of Pulmonology, University of San Francisco, San Francisco, USA.
Kasha P SinghThe Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, Parkville, Australia.
Melvin SpigelmanTB Alliance, New York, USA.
Stephen H GillespieUniversity of St Andrews Medical School, St Andrews, UK.

Funding

Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
Developing appropriate risk reduction interventions for pre-teensR21MH083308 · NIMH · WITS HEALTH CONSORTIUM (PTY), LTD · PI GRAY, GLENDA E, SIKKEMA, KATHLEEN J · 2008 to 2009
$331k
Medical Research Council MC_U122888469Medical Research Council MC_UU_12023/27NIAID NIH HHS UM1 AI069453NIMH NIH HHS R21 MH083308
6 · The paper itself

Abstract

backgroundThe phase III REMoxTB study prospectively enrolled HIV-positive (with CD4+ count > 250 cells, not on anti-retroviral therapy) and HIV-negative patients. We investigated the incidence of adverse events and cure rates according to HIV status for patients receiving standard TB therapy in the trial.

methodsForty-two HIV-positive cases were matched to 220 HIV-negative controls by age, gender, ethnicity, and trial site using coarsened exact matching. Grade 3 and 4 adverse events (AEs) were summarised by MedDRA System Organ Class. Kaplan-Meier curves for time to first grade 3 or 4 AE were constructed according to HIV status with hazard ratios calculated. Patients were considered cured if they were culture negative 18 months after commencing therapy with ≥2 consecutive negative culture results.

resultsTwenty of 42 (47.6%) HIV-positive and 34 of 220 (15.5%) HIV-negative patients experienced ≥1 grade 3 or 4 AE, respectively. The majority of these were hepatobiliary disorders that accounted for 12 of 40 (30.0%) events occurring in 6 of 42 (14.3%) HIV-positive patients and for 15 of 60 (25.0%) events occurring in 9 of 220 (4.1%) HIV-negative patients. The median time to first grade 3 or 4 AE was 54 days (IQR 15.5-59.0) for HIV-positive and 29.5 days (IQR 9.0-119.0) for HIV-negative patients, respectively. The hazard ratio for experiencing a grade 3 or 4 AE among HIV-positive patients was 3.25 (95% CI 1.87-5.66, p < 0.01). Cure rates were similar, with 38 of 42 (90.5%) HIV-positive and 195 of 220 (88.6%) HIV-negative patients (p = 0.73) cured at 18 months.

conclusionsHIV-positive patients receiving standard TB therapy in the REMoxTB study were at greater risk of adverse events during treatment but cure rates were similar when compared to a matched sample of HIV-negative patients.

Indexed as

HIV SeropositivityAdultAntitubercular AgentsEthambutolFemaleHumansIncidenceIsoniazidLinear ModelsMaleMultivariate AnalysisProspective StudiesPyrazinamideRifampinRisk FactorsTreatment OutcomeAntitubercular AgentsEthambutolIsoniazidPyrazinamideRifampinAdverse eventsClinical trialsHIVTuberculosis

Identifiers

PMID31412895
PMCPMC6694514

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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.