Evidence map›Paper›PMID 24521425›Full record

Trial reportBMC pediatrics2014

Sex differences in responses to antiretroviral treatment in South African HIV-infected children on ritonavir-boosted lopinavir- and nevirapine-based treatment.

Stephanie Shiau, Louise Kuhn, Renate Strehlau, Leigh Martens, Helen McIlleron, Sandra Meredith, Lubbe Wiesner, Ashraf Coovadia, Elaine J Abrams, Stephen M Arpadi

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00117728 (Clinical Relevance of Nevirapine Resistance), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
0.9field-weighted citation impact, top 25% 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.

NCT00117728 phase3unknown statusnot on this map

Clinical Relevance of Nevirapine Resistance

TypeinterventionalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2005 to 2010Enrolled250ConditionsAIDS, HIV InfectionsArmsnevirapine
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 24 citations in OpenAlex.

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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

10 authors at 3 institutions in 2 countries.

Stephanie Shiau
Louise Kuhn
Renate Strehlau
Leigh Martens
Helen McIlleron
Sandra Meredith
Lubbe Wiesner
Ashraf Coovadia
Elaine J Abrams
Stephen M ArpadiGertrude H, Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY USA. sma2@columbia.edu.
Columbia University · USUniversity of Cape Town · ZAUniversity of the Witwatersrand · ZA

Funding

Host epigenetic and mitochondrial function in HIV-infected childrenR01HD073952 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI KUHN, LOUISE · 2012 to 2016
$3.7M
Bone health in perinatally HIV-infected South African children on antiretroviralsR01HD073977 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI ARPADI, STEPHEN M, YIN, MICHAEL T · 2012 to 2016
$3.6M
Treatment Options for Protease Inhibitor Exposed ChildrenR01HD061255 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI KUHN, LOUISE · 2010 to 2014
$2.9M
Clinical Relevance of Transient Nevirapine ResistanceR01HD047177 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI KUHN, LOUISE · 2004 to 2008
$2.6M
NICHD NIH HHS HD 073952NICHD NIH HHS HD 073977NICHD NIH HHS HD 47177NICHD NIH HHS HD 61255NICHD NIH HHS R01 HD047177NICHD NIH HHS R01 HD061255NICHD NIH HHS R01 HD073952
6 · The paper itself

Abstract

backgroundWhile studies of HIV-infected adults on antiretroviral treatment (ART) report no sex differences in immune recovery and virologic response but more ART-associated complications in women, sex differences in disease progression and response to ART among children have not been well assessed. The objective of this study was to evaluate for sex differences in response to ART in South African HIV-infected children who were randomized to continue ritonavir-boosted lopinavir (LPV/r)-based ART or switch to nevirapine-based ART.

methodsART outcomes in HIV-infected boys and girls in Johannesburg, South Africa from 2005-2010 were compared. Children initiated ritonavir-boosted lopinavir (LPV/r)-based ART before 24 months of age and were randomized to remain on LPV/r or switch to nevirapine-based ART after achieving viral suppression. Children were followed for 76 weeks post-randomization and then long-term follow up continued for a minimum of 99 weeks and maximum of 245 weeks after randomization. Viral load, CD4 count, lipids, anthropometrics, drug concentrations, and adherence were measured at regular intervals. Outcomes were compared between sexes within treatment strata.

resultsA total of 323 children (median age 8.8 months, IQR 5.1-13.5), including 168 boys and 155 girls, initiated LPV/r-based ART and 195 children were randomized. No sex differences in risk of virological failure (confirmed viral load >1000 copies/mL) by 156 weeks post-randomization were observed within either treatment group. Girls switched to nevirapine had more robust CD4 count improvement relative to boys in this group through 112 weeks post-randomization. In addition, girls remaining on LPV/r had higher plasma concentrations of ritonavir than boys during post-randomization visits. After a mean of 3.4 years post-randomization, girls remaining on LPV/r also had a higher total cholesterol:HDL ratio and lower mean HDL than boys on LPV/r.

conclusionsSex differences are noted in treated HIV-infected children even at a young age, and appear to depend on treatment regimen. Future studies are warranted to determine biological mechanisms and clinical significance of these differences.

trial registrationClinicalTrials.gov Identifier: NCT00117728.

Indexed as

Anti-HIV AgentsChild, PreschoolDrug Therapy, CombinationFemaleHIV InfectionsHumansInfantLopinavirMaleNevirapineRitonavirSex FactorsSouth AfricaTreatment OutcomeAnti-HIV AgentsLopinavirNevirapineRitonavir

Identifiers

PMID24521425
PMCPMC3927631
OpenAlexW2132535766

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.