Evidence map›Paper›PMID 32448902›Full record

Trial reportJournal of the Pediatric Infectious Diseases Society2021

Pharmacokinetics and Safety of a Raltegravir-Containing Regimen in Children Aged 4 Weeks to 2 Years Living With Human Immunodeficiency Virus and Receiving Rifampin for Tuberculosis.

Paul Krogstad, Pearl Samson, Edward P Acosta, Jack Moye, Ellen Townley, Sarah Bradford, Emily Brown, Kayla Denson, Bobbie Graham, Laura Hovind and 8 more

Registry-linked trialOpen access · greenAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the Pediatric Infectious Diseases Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01751568 (Phase I/II Dose-Finding, Safety, Tolerance, and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 40% 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.

NCT01751568 phase1 / phase2completednot on this map

Phase I/II Dose-Finding, Safety, Tolerance, and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-Infected and TB Co-Infected Infants and Children

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2014 to 2019Enrolled40ConditionsHIV Infections, TuberculosisArmsRaltegravir
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
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

18 authors at 10 institutions in 2 countries.

Paul KrogstadDepartments of Pediatrics and Molecular and Medical Pharmacology, David Geffen School of Medicine at Los Angeles, Los Angeles, California, USA.
Pearl SamsonStatistical and Data Management Center, Frontier Science Foundation/Harvard T.H. Chan School of Public Health Boston, Massachusetts, USA.
Edward P AcostaDepartment of Pharmacology and Toxicology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Jack MoyeMaternal and Pediatric Infectious Disease Branch, Division of Extramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, USA.
Ellen TownleyColumbus Technologies and Services, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
Sarah BradfordFHI360, Durham, North Carolina, USA.
Emily BrownFHI360, Durham, North Carolina, USA.
Kayla DensonFrontier Science Foundation, Inc, Amherst, New York, USA.
Bobbie GrahamFrontier Science Foundation, Inc, Amherst, New York, USA.
Laura HovindFrontier Science Foundation, Inc, Amherst, New York, USA.
Thucuma SiseColumbus Technologies and Services, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
Hedy TepplerGlobal Clinical Development - Infectious Diseases, Merck & Co, Inc, Kenilworth, New Jersey, USA.
Sisinyana Ruth MathibaPerinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa.
Lee FairlieWits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Jana L WincklerDesmond Tutu TB Centre, Department of Paediatrics, Stellenbosch University, Cape Town South Africa.
Gretchen SladeDepartment of Paediatrics and Child Health, Family Clinical Research Unit, Stellenbosch University, Cape Town, South Africa.
Tammy MeyersDepartment of Paediatrics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
International Maternal Pediatric Adolescent AIDS Clinical Trials Network P1101 Team
Frontier Science & Technology Research Foundation · USUniversity of the Witwatersrand · ZAColumbus Technologies and Services (United States) · USFamily Health International 360 · USDesmond Tutu HIV Foundation · ZAEunice Kennedy Shriver National Institute of Child Health and Human Development · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USStellenbosch University · ZAUniversity of Alabama at Birmingham · USUniversity of California, Los Angeles · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
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
NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI106716NICHD NIH HHS HHSN275201800001CNICHD NIH HHS HHSN275201800001INIMH NIH HHS R21 MH083308
6 · The paper itself

Abstract

Pharmacological interactions limit treatment options for children living with human immunodeficiency virus (HIV) and tuberculosis (TB). We found that 12 mg/kg twice daily raltegravir chewable tablets (administered after crushing) safely achieved pharmacokinetic targets in children living with HIV aged 4 weeks to <2 years receiving concurrent rifampin to treat TB. CLINICAL TRIALS REGISTRATION: NCT01751568.

Indexed as

Anti-HIV AgentsHIV InfectionsTuberculosisChildHIVHumansRaltegravir PotassiumRifampinAnti-HIV AgentsRaltegravir PotassiumRifampinantiretroviral therapydrug interactionspediatricsrifampintuberculosis

Identifiers

PMID32448902
PMCPMC7996637
OpenAlexW3026250125

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.