Evidence map›Paper›PMID 35583344›Full record

ArticleAntimicrobial agents and chemotherapy2022

The Effect of Rifampicin on Darunavir, Ritonavir, and Dolutegravir Exposure within Peripheral Blood Mononuclear Cells: a Dose Escalation Study.

Amedeo De Nicolò, Andrea Calcagno, Ilaria Motta, Elisa De Vivo, Antonio D'Avolio, Giovanni Di Perri, Lubbe Wiesner, Isma-Eel Ebrahim, Gary Maartens, Catherine Orrell and 1 more

Open access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 45% 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.

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

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. 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

11 authors at 3 institutions in 2 countries.

Amedeo De Nicolò *Laboratory of Clinical Pharmacology and Pharmacogenetics, Department of Medical Sciences, University of Turingrid.7605.4, Turin, Italy.ORCID 0000-0002-5973-9948
Andrea Calcagno *Unit of Infectious Diseases, Department of Medical Sciences, University of Turingrid.7605.4, Turin, Italy.ORCID 0000-0003-2534-8815
Ilaria MottaUnit of Infectious Diseases, Department of Medical Sciences, University of Turingrid.7605.4, Turin, Italy.
Elisa De VivoLaboratory of Clinical Pharmacology and Pharmacogenetics, Department of Medical Sciences, University of Turingrid.7605.4, Turin, Italy.
Antonio D'AvolioLaboratory of Clinical Pharmacology and Pharmacogenetics, Department of Medical Sciences, University of Turingrid.7605.4, Turin, Italy.ORCID 0000-0002-1321-4126
Giovanni Di PerriUnit of Infectious Diseases, Department of Medical Sciences, University of Turingrid.7605.4, Turin, Italy.
Lubbe WiesnerDivision of Clinical Pharmacology, Department of Medicine, University of Cape Towngrid.7836.a, Cape Town, South Africa.ORCID 0000-0002-9070-8699
Isma-Eel EbrahimDivision of Clinical Pharmacology, Department of Medicine, University of Cape Towngrid.7836.a, Cape Town, South Africa.
Gary MaartensDivision of Clinical Pharmacology, Department of Medicine, University of Cape Towngrid.7836.a, Cape Town, South Africa.ORCID 0000-0003-3080-6606
Catherine OrrellDesmond Tutu HIV Centre, Institute of Infectious Diseases and Molecular Medicine (IDM) and Department of Medicine, University of Cape Towngrid.7836.a, Cape Town, South Africa.
Helen McIlleronDivision of Clinical Pharmacology, Department of Medicine, University of Cape Towngrid.7836.a, Cape Town, South Africa.ORCID 0000-0002-0982-6226
University of Turin · ITUniversity of Cape Town · ZADesmond Tutu HIV Foundation · ZA

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
NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI106701Wellcome Trust 206379/Z/17/Z
6 · The paper itself

Abstract

Ritonavir-boosted darunavir (DRV/r) and dolutegravir (DTG) are affected by induction of metabolizing enzymes and efflux transporters caused by rifampicin (RIF). This complicates the treatment of people living with HIV (PLWH) diagnosed with tuberculosis. Recent data showed that doubling DRV/r dose did not compensate for this effect, and hepatic safety was unsatisfactory. We aimed to evaluate the pharmacokinetics of DRV, ritonavir (RTV), and DTG in the presence and absence of RIF in peripheral blood mononuclear cells (PBMCs). PLWH were enrolled in a dose-escalation crossover study with 6 treatment periods of 7 days. Participants started with DRV/r 800/100 mg once daily (QD), RIF and DTG were added before the RTV dose was doubled, and then they received DRV/r 800/100 twice daily (BD) and then 1,600/200 QD or vice versa. Finally, RIF was withdrawn. Plasma and intra-PBMC drug concentrations were measured through validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods. Seventeen participants were enrolled but only 4 completed all study phases due to high incidence of liver toxicity. Intra-PBMC DRV trough serum concentration (

Indexed as

Anti-HIV AgentsHIV InfectionsHIV Protease InhibitorsChromatography, LiquidCross-Over StudiesDarunavirDolutegravirHeterocyclic Compounds, 3-RingHumansLeukocytes, MononuclearOxazinesPiperazinesPyridonesRifampinRitonavirTandem Mass SpectrometryAnti-HIV AgentsDarunavirDolutegravirHeterocyclic Compounds, 3-RingHIV Protease InhibitorsOxazinesPiperazinesPyridonesRifampinRitonavirdarunavirdolutegravirdrug-drug interactiondrug interactionsPBMCpharmacokineticsrifampicin

Identifiers

PMID35583344
PMCPMC9211429
OpenAlexW4280562247

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.