Evidence map›Paper›PMID 41666019›Full record

Trial reportThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2025

Effect of HIV on bedaquiline and delamanid pharmacokinetics in patients with multidrug-resistant TB.

J Shenje, G Maartens, L Moran, Y Cramer, J D L Rios, A Diacon, K Dooley, R Court

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2025. 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

8 authors.

J ShenjeSouth African Tuberculosis Vaccine Initiative, University of Cape Town, Cape Town, South Africa.
G MaartensDivision of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
L MoranSocial and Scientific Systems, A DLH Company, Silver Spring, MD, USA.
Y CramerHarvard T.H. Chan School of Public Health, Boston, MA, USA.
J D L RiosAsociacion Civil Impacta Salud y Educacion, Lima, Peru.
A DiaconTASK, Cape Town, South Africa.
K DooleyVanderbilt University Medical Center, Nashville, TN, USA.
R CourtDivision of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.

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
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
THE IMPACTA PERU CLINICAL TRIALS UNITUM1AI069438 · NIAID · ASOCIACION CIVIL IMPACTA SALUD Y EDUCACN · PI Alberto La Rosa, Jorge Luis Sanchez · 2012 to 2026
$43.2M
University of Cape Town Clinical Trials Unit (UCTCTU)UM1AI069519 · NIAID · UNIVERSITY OF CAPE TOWN · PI Linda-Gail Bekker · 2012 to 2026
$36.3M
Stellenbosch University Clinical Trial Unit, Cape Town, South AfricaUM1AI069521 · NIAID · STELLENBOSCH UNIVERSITY · PI Shaun Barnabas, Anneke Catharina Hesseling · 2012 to 2026
$21.5M
NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069438NIAID NIH HHS UM1 AI069519NIAID NIH HHS UM1 AI069521NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

<sec><title>BACKGROUND</title>Bedaquiline and delamanid are key drugs in the treatment of multidrug-resistant TB. It is unclear whether HIV affects the pharmacokinetics of bedaquiline and delamanid.</sec><sec><title>METHODS</title>Participants with multidrug-resistant TB were randomised to treatment with bedaquiline, delamanid, or both, plus a standard-of-care treatment. Intensive pharmacokinetic sampling was performed after 8 weeks of therapy. We performed non-compartment analysis to describe bedaquiline and delamanid pharmacokinetics, comparing exposures between HIV-positive and HIV-negative participants using geometric mean ratios (GMRs), and explored covariates associated with bedaquiline and delamanid AUC, using multivariable regression modelling.</sec><sec><title>RESULTS</title>Twenty-six participants were assigned to bedaquiline, 25 received delamanid, and 24 received both drugs. Fifty and 49 participants were treated with bedaquiline and delamanid, respectively. The GMR (90% confidence interval [CI]) of bedaquiline AUC

Indexed as

Antitubercular AgentsDiarylquinolinesHIV InfectionsNitroimidazolesOxazolesTuberculosis, Multidrug-ResistantAdultArea Under CurveFemaleHumansMaleMiddle AgedAntitubercular AgentsbedaquilineDiarylquinolinesNitroimidazolesOPC-67683Oxazoles

Identifiers

PMID41666019
PMCPMC13587708

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.