Publications by authors named "S Chalermpantmetagul"
D3/Penta 21 clinical trial design: A randomised non-inferiority trial with nested drug licensing substudy to assess dolutegravir and lamivudine fixed dose formulations for the maintenance of virological suppression in children with HIV-1 infection, aged 2 to 15 years.
Contemp Clin Trials
July 2024
Background: There is increasing interest in utilising two-drug regimens for HIV treatment with the goal of reducing toxicity and improve acceptability. The D3 trial evaluates the efficacy and safety of DTG/3TC in children and adolescents and includes a nested pharmacokinetics(PK) substudy for paediatric drug licensing.
Methods: D3 is an ongoing open-label, phase III, 96-week non-inferiority randomised controlled trial(RCT) conducted in South Africa, Spain, Thailand, Uganda and the United Kingdom.
Nucleoside/nucleotide reverse transcriptase inhibitor sparing regimen with once daily integrase inhibitor plus boosted darunavir is non-inferior to standard of care in virologically-suppressed children and adolescents living with HIV - Week 48 results of the randomised SMILE Penta-17-ANRS 152 clinical trial.
EClinicalMedicine
June 2023
Article Synopsis
- The SMILE trial investigated the effectiveness and safety of switching children living with HIV to a treatment regimen of integrase inhibitor (INSTI) and boosted darunavir (DRV/r), compared to continuing standard triple antiretroviral therapy (SOC).
- The trial enrolled 318 participants aged 6-18 from multiple regions, finding that switching to the new regimen showed non-inferiority in maintaining low HIV-RNA levels after 48 weeks.
- The results indicated no significant differences in safety between the two groups, but the INSTI + DRV/r group had greater increases in weight and BMI compared to those on SOC.
Background: Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).
Methods: We conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non-dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan-Meier method.
Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents and young adults (BREATHER): Extended follow-up results of a randomised, open-label, non-inferiority trial.
PLoS One
July 2018
Background: Weekends off antiretroviral therapy (ART) may help engage HIV-1-infected young people facing lifelong treatment. BREATHER showed short cycle therapy (SCT; 5 days on, 2 days off ART) was non-inferior to continuous therapy (CT) over 48 weeks. Planned follow-up was extended to 144 weeks, maintaining original randomisation.
View Article and Find Full Text PDFSetting: Centres participating in the Paediatric European Network for Treatment of AIDS (PENTA), including Thailand and Brazil.
Objective: To describe the incidence, presentation, treatment and treatment outcomes of tuberculosis (TB) in human immunodeficiency virus (HIV) infected children.
Design: Observational study of TB diagnosed in HIV-infected children in 2011-2013.