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View article: Changes in Body Mass Index in Children and Adolescents Living With Human Immunodeficiency Virus in Europe and Thailand Starting Dolutegravir
Changes in Body Mass Index in Children and Adolescents Living With Human Immunodeficiency Virus in Europe and Thailand Starting Dolutegravir Open
Background Excess weight gain has been reported in some adults on dolutegravir (DTG), but data in children/adolescents living with human immunodeficiency virus (CALHIV) are limited. Methods CALHIV aged 2–17 years at DTG start from 15 obser…
View article: Virological outcomes and genotypic resistance on dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial
Virological outcomes and genotypic resistance on dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial Open
Penta Foundation, ViiV Healthcare, and UK Medical Research Council.
View article: Statistical Analysis Plan for the “Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia” clinical trial
Statistical Analysis Plan for the “Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia” clinical trial Open
Background The EMPIRICAL trial aims to assess safety and efficacy of an empirical treatment against cytomegalovirus (CMV) and tuberculosis (TB) compared to standard of care (SoC), on adverse events and 15-day and 1-year mortality among inf…
View article: High mortality following early initiation of antiretroviral therapy in infants living with HIV from three African countries
High mortality following early initiation of antiretroviral therapy in infants living with HIV from three African countries Open
Early Treated Perinatally HIV Infected Individuals: Improving Children's Actual Life (EPIICAL) is a research consortium funded by ViiV Healthcare and led by Penta Foundation. The funder was not involved in the analysis and interpretation o…
View article: Swissped-RECOVERY: masked independent adjudication for the interpretation of non-randomised treatment in a two-arm open-label randomised controlled trial (methylprednisolone vs immunoglobulins) in Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS) involving 10 secondary and tertiary paediatric hospitals in Switzerland
Swissped-RECOVERY: masked independent adjudication for the interpretation of non-randomised treatment in a two-arm open-label randomised controlled trial (methylprednisolone vs immunoglobulins) in Paediatric Inflammatory Multisystem Syndrome Temporally Associated with SARS-CoV-2 (PIMS-TS) involving 10 secondary and tertiary paediatric hospitals in Switzerland Open
Objectives In trials of acute severe infections or inflammations frequent administration of non-randomised treatment (ie, intercurrent event) in response to clinical events is expected. These events may affect the interpretation of trial f…
View article: Low unspliced cell-associated HIV RNA in early treated adolescents living with HIV on long suppressive ART
Low unspliced cell-associated HIV RNA in early treated adolescents living with HIV on long suppressive ART Open
Introduction Initiation of antiretroviral treatment (ART) in patients early after HIV-infection and long-term suppression leads to low or undetectable levels of HIV RNA and cell-associated (CA) HIV DNA and RNA. Both CA-DNA and CA-RNA, over…
View article: Plasma Protein Biomarkers Distinguish Multisystem Inflammatory Syndrome in Children From Other Pediatric Infectious and Inflammatory Diseases
Plasma Protein Biomarkers Distinguish Multisystem Inflammatory Syndrome in Children From Other Pediatric Infectious and Inflammatory Diseases Open
Background: Multisystem inflammatory syndrome in children (MIS-C) is a rare but serious hyperinflammatory complication following infection with severe acute respiratory syndrome coronavirus 2. The mechanisms underpinning the pathophysiolog…
View article: Infective Endocarditis in Pediatric Patients: A Decade of Insights from a Leading Spanish Heart Surgery Reference Center
Infective Endocarditis in Pediatric Patients: A Decade of Insights from a Leading Spanish Heart Surgery Reference Center Open
Purpose Infective endocarditis (IE) is a rare disease in children and is associated with significant morbimortality. In recent years, significant changes have occurred in pediatric care that could have influenced the microbiology and prese…
View article: Renal Function Impairment in Children With Congenital Cytomegalovirus Infection: A Cross-sectional Study
Renal Function Impairment in Children With Congenital Cytomegalovirus Infection: A Cross-sectional Study Open
Background: We aimed to determine the prevalence and severity of glomerular and tubular renal dysfunction by means of urinalysis in infants and toddlers with congenital cytomegalovirus infection (cCMV) and their association with cCMV disea…
View article: PA-655 Severe pneumonia is associated with worse neurocognitive function among infants living with HIV
PA-655 Severe pneumonia is associated with worse neurocognitive function among infants living with HIV Open
Background Despite reduction of HIV-associated mortality in children with the implementation of antiretroviral treatment (ART), HIV-associated neurocognitive deficits are still of great concern. These are thought to result mainly from intr…
View article: OA-286 Plasma concentrations of first line antituberculosis drugs in infants with HIV and severe pneumonia: a pharmacokinetic sub-study of the empirical trial
OA-286 Plasma concentrations of first line antituberculosis drugs in infants with HIV and severe pneumonia: a pharmacokinetic sub-study of the empirical trial Open
Background Infants living with HIV are at high risk of tuberculosis and death. Optimal antituberculosis therapy is essential for favourable clinical outcomes particularly in severely ill children. Using WHO-recommended weight-band dosing, …
View article: OA-429 High mortality in African infants living with HIV hospitalized with severe pneumonia
OA-429 High mortality in African infants living with HIV hospitalized with severe pneumonia Open
Background Children with advanced HIV disease (AHD) are at an increased risk of morbidity and mortality. We describe mortality rates among infants with AHD hospitalized with severe pneumonia. Methods EMPIRICAL is an ongoing Phase II-III, o…
View article: PA-455 Bedside ultrasound for the diagnosis of tuberculosis in HIV-positive infants hospitalized with severe pneumonia
PA-455 Bedside ultrasound for the diagnosis of tuberculosis in HIV-positive infants hospitalized with severe pneumonia Open
Background Tuberculosis (TB) diagnosis is challenging in children, particularly in infants, contributing to high TB-related mortality. Up to 30% of infants with pulmonary TB have concurrent extrapulmonary disease, with findings that can fr…
View article: PA-477 Building a national network for inpatient pediatric clinical research in Mozambique
PA-477 Building a national network for inpatient pediatric clinical research in Mozambique Open
Background Universidade Eduardo Mondlane (UEM) and Hospital Central de Maputo (HCM) were invited to join a consortium of established pediatric research groups from 5 other sub-Saharan Africa countries in a proposal for the EMPIRICAL trial,…
View article: PA-450 Laboratory diagnosis of Pneumocystis jirovecii in HIV-positive infants with severe pneumonia using non-invasive samples
PA-450 Laboratory diagnosis of Pneumocystis jirovecii in HIV-positive infants with severe pneumonia using non-invasive samples Open
Background The laboratory diagnosis of P. jirovecii pneumonia (PCP) is typically based on microscopic observation of cysts and trophic forms on deep respiratory specimens. In low-income countries, access to bronchoalveolar lavage is limite…
View article: Twice-Daily Dosing of Dolutegravir in Infants on Rifampicin Treatment: A Pharmacokinetic Substudy of the EMPIRICAL Trial
Twice-Daily Dosing of Dolutegravir in Infants on Rifampicin Treatment: A Pharmacokinetic Substudy of the EMPIRICAL Trial Open
Background We evaluated dolutegravir pharmacokinetics in infants with human immunodeficiency virus (HIV) receiving dolutegravir twice daily (BID) with rifampicin-based tuberculosis (TB) treatment compared with once daily (OD) without rifam…
View article: PACTA-Ped: Antimicrobial stewardship programme in a tertiary care hospital in Spain
PACTA-Ped: Antimicrobial stewardship programme in a tertiary care hospital in Spain Open
Our ASP achieved a significant decrease in the use of broad-spectrum antibiotics and antifungals. The costs associated with antimicrobial prescribing decreased following the introduction of the ASP, which was a cost-effective action in thi…
View article: First-Line Antituberculosis Drug Concentrations in Infants With HIV and a History of Recent Admission With Severe Pneumonia
First-Line Antituberculosis Drug Concentrations in Infants With HIV and a History of Recent Admission With Severe Pneumonia Open
Optimal antituberculosis therapy is essential for favorable clinical outcomes. Peak plasma concentrations of first-line antituberculosis drugs in infants with living HIV receiving WHO-recommended dosing were low compared with reference val…
View article: COVID-19 and MIS-C treatment in children—results from an international survey
COVID-19 and MIS-C treatment in children—results from an international survey Open
Children have been mostly excluded from COVID-19 clinical trials, and, as a result, most medicines approved for COVID-19 have no pediatric indication. In addition, access to COVID-19 therapeutics remains limited. Collecting physicians’ exp…
View article: The epidemiology of adolescents living with perinatally acquired HIV: A cross-region global cohort analysis
The epidemiology of adolescents living with perinatally acquired HIV: A cross-region global cohort analysis Open
Background: Globally, the population of adolescents living with perinatally acquired HIV (APHs) continues to expand. In this study, we pooled data from observational pediatric HIV cohorts and cohort networks, allowing comparisons of adoles…