Evidence map›Paper›PMID 35943252›Full record

Trial reportAntimicrobial agents and chemotherapy2022

Population Pharmacokinetic Modeling and Simulation of Rifapentine Supports Concomitant Antiretroviral Therapy with Efavirenz and Non-Weight Based Dosing.

Michelle M Pham, Anthony T Podany, Noluthando Mwelase, Khuanchai Supparatpinyo, Lerato Mohapi, Amita Gupta, Wadzanai Samaneka, Ayotunde Omoz-Oarhe, Deborah Langat, Constance A Benson and 3 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 36% 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

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. 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

13 authors at 8 institutions in 4 countries.

Michelle M PhamAntiviral Pharmacology Laboratory, UNMC Center for Drug Discovery, University of Nebraska Medical Centergrid.266813.8, Omaha, Nebraska, USA.
Anthony T PodanyAntiviral Pharmacology Laboratory, UNMC Center for Drug Discovery, University of Nebraska Medical Centergrid.266813.8, Omaha, Nebraska, USA.
Noluthando MwelaseUniversity of the Witwatersrand Helen Joseph CRS, Johannesburg, South Africa.
Khuanchai SupparatpinyoChiang Mai University, Chiang Mai, Thailand.
Lerato MohapiSoweto ACTG CRS, Perinatal HIV Research Unit, Johannesburg, South Africa.
Amita GuptaJohns Hopkins Hospital, Baltimore, Maryland, USA.
Wadzanai SamanekaMilton Park CRS, Harare, Zimbabwe.
Ayotunde Omoz-OarheMolepolole Clinical Research Site, Molepolole, Botswana.
Deborah LangatKenya Medical Research Institute/Walter Reed Project Clinical Research Center CRS, Kericho, Kenya.
Constance A BensonUniversity of California San Diego, San Diego, California, USA.
Richard E ChaissonJohns Hopkins University School of Medicinegrid.471401.7, Center for Tuberculosis Research, Baltimore, Maryland, USA.
Susan SwindellsDivision of Infectious Diseases, Department of Internal Medicine, University of Nebraska Medical Centergrid.266813.8, Omaha, Nebraska, USA.
Courtney V FletcherAntiviral Pharmacology Laboratory, UNMC Center for Drug Discovery, University of Nebraska Medical Centergrid.266813.8, Omaha, Nebraska, USA.ORCID 0000-0002-3703-7849
University of Nebraska Medical Center · USChiang Mai University · THJohns Hopkins Hospital · USJohns Hopkins University · USKenya Medical Research Institute · KEPerinatal HIV Research Unit · ZAUniversity of California San Diego · USUniversity of the Witwatersrand · 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
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
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
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
The Johns Hopkins Baltimore-Washington-India Clinical Trials Unit (BWI CTU)UM1AI069465 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Charles W. Flexner, Amita Gupta · 2012 to 2026
$34.1M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
NIAID NIH HHS K23 AI134307NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069436NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069399NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069456NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069465NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

The Brief Rifapentine-Isoniazid Efficacy for TB Prevention/A5279 trial demonstrated a 1-month daily regimen of rifapentine and isoniazid was noninferior to 9 months of isoniazid alone for preventing TB in persons living with HIV (PLWH). Our objective was to evaluate rifapentine pharmacokinetics in trial participants receiving antiretroviral therapy (ART) and perform simulations to compare weight-based rifapentine dosing with a standard, fixed dose. Nonlinear mixed effect modeling was used to estimate rifapentine and 25-desacetyl rifapentine population pharmacokinetic characteristics. The pharmacokinetic model was validated using a nonparametric bootstrap and visual predictive checks. Monte Carlo simulations were performed to compare weight-based and fixed dose regimens. Rifapentine and 25-desacetyl rifapentine concentrations (347 of each; 185 participants) were each described with a one-compartment model with one-way conversion between rifapentine and 25-desacetyl rifapentine. The absorption rate was nearly doubled in fed versus fasting states. Rifapentine clearance was increased 31% in those receiving efavirenz (EFV)-based versus nevirapine-based ART. Metabolite clearance was allometrically scaled with fat-free mass. Simulations showed lower rifapentine exposures with weight-based compared with fixed dosing. With 10 mg/kg weight-based regimens, 26% and 62% of simulated exposures in <35 kg and 35-45 kg weight classes were above target (AUC

Indexed as

HIV InfectionsIsoniazidAlkynesAnti-Retroviral AgentsAntitubercular AgentsBenzoxazinesCyclopropanesHumansNevirapineRifampinAlkynesAnti-Retroviral AgentsAntitubercular AgentsBenzoxazinesCyclopropanesefavirenzIsoniazidNevirapineRifampinrifapentineantiretroviral therapyHIV/AIDSMycobacterium tuberculosispopulation pharmacokineticsrifapentinetuberculosis

Identifiers

PMID35943252
PMCPMC9487628
OpenAlexW4292401005

What Socratic 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 Socratic graph.