Study update

An optimised dosing regimen vs. a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in infants less than 90 days: the NeoVanc trial

14 Feb, 2023

Background: Vancomycin remains one of the most widely prescribed antibiotics for Gram-positive neonatal late onset sep- sis (LOS). Robust neonatal clinical outcome data comparing different vancomycin dosing regimens is lacking.…
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Interim pharmacokinetic analysis of a multi-centre randomised open label phase IIb study in neonates to validate the meta-analysis population pharmacokinetic model used to simulate an optimised dosing regimen in neonates and infants aged < 90 days: the NeoVanc trial

14 Feb, 2023

Background: Vancomycin remains one of the most widely prescribed antibiotics for Gram-positive neonatal late onset sepsis (LOS), however, a consensus on optimal vancomycin dosing and duration is lacking. Robust neonatal…
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Incidence of SARS-CoV-2 infection and clinical characteristics in children and young people living with HIV in Europe

23 Aug, 2022

Background: HIV has been shown to be independently associated with increased COVID-19 mortality in adults, but data in children and young people living with HIV (CYPLHIV) are limited. We assessed…
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Effect of dolutegravir on folate and vitamin B12 status among HIV- infected children and adolescents in the ODYSSEY trial

02 Aug, 2022

Abstract Background: Neural tube defects (NTDs) are known to be associated with maternal folate and vitamin B12 deficiency, and initial surveillance studies suggested an increased risk of NTDs among infants conceived…
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The subphenotypes of early-treated children living with HIV-1

01 Aug, 2022

Abstract Subphenotypes have been identified in several heterogeneous diseases. Having a specific subphenotype often has therapeutic implications or impacts disease progression. In this study, we aimed to assess if children…
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ZIKAction paediatric registry: maternal characteristics and clinical, radiological, and follow-up features of children born with congenital zika infection in brazil

01 Aug, 2022

Background: In 2015, Brazil experienced an unexpected increase in newborns with microcephaly. Subsequently, the association between microcephaly and Congenital Zika Infection (CZI) was confirmed. Aims: This study, part of the…
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The D3 study has screened the first 2 children

27 Apr, 2022

Great day for the D3 study, today. The first 2 children have been screened for the study at the Prapokklao Hospital in Thailand. Thanks to the MRC CTU and the…
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Birth outcomes following prenatal exposure to dolutegravir: the DOLOMITE-EPPICC study

18 Mar, 2022

Abstract Dolutegravir (DTG) is recommended and widely used during pregnancy for maternal viral suppression and preventing perinatal transmission of HIV. Our objective is to assess pregnancy and neonatal outcomes including…
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2-year outcome of early treated infants in Sub-Saharan Africa

18 Mar, 2022

Abstract The real-world evolution of very early treated children born with HIV in high-prevalence settings during first years of life is unclear. We assessed the probability of death, progression to…
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Dolutegravir-based ART is superior to NNRTI- and PI-based ART in infants, children and adolescents living with HIV (combined results of the main trial and the ‘under 14kg’ cohort)

28 Sep, 2021

Abstract ODYSSEY Internationalmulti-centre,randomised96-weeknon- inferiority trialWeaimedtocompareefficacyandsafetyofDTG-basedART with standard-of-care in children and adolescents starting first-line ART (ODYSSEY A) or second-line (ODYSSEY B) Main trial enrolled children≥14kg Aim to enrol ≥700 children: 310…
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Cheaper HIV treatment for children: a report in The Lancet

20 Dec, 2020

A new pricing agreement will bring the cost of treatment for children with HIV down from US$480 to less than $120.
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ODYSSEY: recruitment to the main trial completed!

23 Oct, 2019

ODYSSEY has reached a major milestone by completing the recruitment of participants to the main trial. A big thank you to all the sites and everyone else for their hard…
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SMILE: Enrolment target of 300 patients achieved today!

08 Aug, 2019

We are thrilled to bring you the news that the Penta-sponsored clinical trial, SMILE, has hit its enrolment target with the recruitment of its 300th patient. The patient was enrolled at the Kryvyi…
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SMILE clinical trial: 200th patient enrolled

18 Jun, 2019

A major new milestone has been achieved in the Penta-sponsored clinical trial SMILE, where patient No. 200 has been recruited today. The patient was enrolled at Baylor in Uganda.
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SMILE Clinical Trial: 100th Patient Enrolled

04 Apr, 2019

The Penta-sponsored clinical trial SMILE has achieved a significant milestone by recruiting its 100th patient yesterday. The patient was enrolled at the Perinatal HIV Research Unit (PHRU) in Soweto, South…
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NeoVanc: pivotal achievement of 200 participants enrolled in the study

15 Feb, 2019

We are pleased to celebrate the milestone achievement of the randomisation of 200 participants in the NeoVanc project. Congratulations to all the NeoVanc team!
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EPIICAL: enrollment has completed in the CARMA study!

05 Oct, 2018

September saw the CARMA study complete its enrollment target of 40 patients. Reservoir size assays have been performed, and primary statistical analyses are ongoing. Over the coming weeks, some results…
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PED-MERMAIDS has reached 50% of enrollment target!

03 Aug, 2018

We are delighted to announce that the study PED-MERMAIDS has surpassed 50% of the enrollment target of 1,000 patients. This is a great achievement and we extend our thanks to…
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