Evidence map›Paper›PMID 22190064›Full record

ArticleClinical pharmacology and therapeutics2012

Assessment of lopinavir pharmacokinetics with respect to developmental changes in infants and the impact on weight band-based dosing.

M Nikanjam, E G Chadwick, B Robbins, C Alvero, P Palumbo, R Yogev, J Pinto, R Hazra, M L Hughes, B E Heckman and 2 more

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 34% 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

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Pediatric AIDS-Therapeutic Successes Built on a Foundation of Pediatric Clinical Pharmacology with Pharmacokinetic-Pharmacodynamic Modeling.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022
    Article
  5. Article
  6. Article
  7. Observational
  8. 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

12 authors at 8 institutions in 2 countries.

M NikanjamUniversity of California, San Diego, La Jolla, California, USA.
E G Chadwick
B Robbins
C Alvero
P Palumbo
R Yogev
J Pinto
R Hazra
M L Hughes
B E Heckman
E V Capparelli
IMPAACT P1030 Team
Harvard University · USNorthwestern University · USUniversity of California, San Diego · USDartmouth College · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USFrontier Science & Technology Research Foundation · USUniversidade Federal de Minas Gerais · BRUniversity of Nebraska Medical Center · 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 Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Statistical/Data Management Center-Pediatric AIDS CTGU01AI041110 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI FENTON, TERRENCE · 1997 to 2006
$38.6M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
INTRACELLULAR PH PHYSIOLOGY IN MESANGIAL CELL GROWTHF32DK009001 · NIDDK · YALE UNIVERSITY · PI SINGH, SATISH K · 1993 to 1995
–
NIAID NIH HHS 1 U01 AI068616NIAID NIH HHS 5 U01 AI41110NIAID NIH HHS AI068632NIAID NIH HHS U01 AI041110NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068632NICHD NIH HHS HHSN267200800001CNIDDK NIH HHS HHSN267200800001GNIDDK NIH HHS N01-DK-9-001
6 · The paper itself

Abstract

Improved antiretroviral therapies are needed for the treatment of HIV-infected infants, given the rapid progression of the disease and drug resistance resulting from perinatal exposure to antiretrovirals. We examined longitudinal pharmacokinetics (PK) data from a clinical trial of lopinavir/ritonavir (LPV/r) in HIV-infected infants in whom therapy was initiated at less than 6 months of age. A population PK analysis was performed using NONMEM to characterize changes in lopinavir (LPV) PK relating to maturational changes in infants, and to assess dosing requirements in this population. We also investigated the relationship between LPV PK and viral dynamic response. Age and ritonavir concentrations were the only covariates found to be significant. Population PK of LPV was characterized by high apparent clearance (CL/F) in young infants, which decreased with increasing age. Although younger infants had lower LPV concentrations, the viral dynamics did not correlate with initial LPV exposure. Monte Carlo simulations demonstrated that WHO weight band-based dosing recommendations predicted therapeutic LPV concentrations and provided drug exposure levels comparable to those resulting from US Food and Drug Administration (FDA)-suggested dosing regimens.

Indexed as

Child DevelopmentDrug CombinationsDrug Dosage CalculationsFemaleHumansInfantInfant, NewbornLopinavirMaleRitonavirDrug CombinationsLopinavirlopinavir-ritonavir drug combinationRitonavir

Identifiers

PMID22190064
PMCPMC3356582
OpenAlexW1988713054

What OpenQuestion holds

Textmetadata
LicenceTDM
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.