3 research outputs found
Risk factors for early mortality on antiretroviral therapy in advanced HIV-infected adults.
CAPRISA, 2017.Abstract available in pdf
Prioritization of invasive alien species with the potential to threaten agriculture and biodiversity in Kenya through horizon scanning
Invasive alien species (IAS) rank among the most significant drivers of species extinction and ecosystem degradation resulting in significant impacts on socio-economic development. The recent exponential spread of IAS in most of Africa is attributed to poor border biosecurity due to porous borders that have failed to prevent initial introductions. In addition, countries lack adequate information about potential invasions and have limited capacity to reduce the risk of invasions. Horizon scanning is an approach that prioritises the risks of potential IAS through rapid assessments. A group of 28 subject matter experts used an adapted methodology to assess 1700 potential IAS on a 5-point scale for the likelihood of entry and establishment, potential socio-economic impact, and impact on biodiversity. The individual scores were combined to rank the species according to their overall potential risk for the country. Confidence in individual and overall scores was recorded on a 3-point scale. This resulted in a priority list of 120 potential IAS (70 arthropods, 9 nematodes, 15 bacteria, 19 fungi/chromist, 1 viroid, and 6 viruses). Options for risk mitigation such as full pest risk analysis and detection surveys were suggested for prioritised species while species for which no immediate action was suggested, were added to the plant health risk register and a recommendation was made to regularly monitor the change in risk. By prioritising risks, horizon scanning guides resource allocation to interventions that are most likely to reduce risk and is very useful to National Plant Protection Organisations and other relevant stakeholders
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Pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir dispersible tablets in infants and children with HIV-1 (IMPAACT P1093): results of an open-label, phase 1–2 trial
BackgroundSafe and potent antiretroviral medications in child-friendly formulations are needed to treat young children living with HIV-1. We aimed to select dosing for a dispersible tablet formulation of dolutegravir that achieved pharmacokinetic exposures similar to those in adults, and was safe and well tolerated in young children.MethodsInternational Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) P1093 is a phase 1-2 ongoing multicentre, open-label, non-comparative study of dolutegravir. A 5 mg dispersible tablet formulation of dolutegravir was studied in children aged 4 weeks to less than 6 years old, weighing at least 3 kg, with HIV RNA of greater than 1000 copies per mL and no previous treatment with integrase strand transfer inhibitor recruited from IMPAACT clinical research sites in Africa, the Americas, and Asia. Doses were selected on the basis of intensive pharmacokinetic evaluation on days 5-10, with safety and tolerability assessed up to 48 weeks. The primary objectives of this study are to evaluate the pharmacokinetics of dolutegravir in combination with optimised background therapy and to establish the dose of dolutegravir that achieves the targeted 24-h trough concentration and 24-h area under the curve for infants, children, and adolescents with HIV-1, to establish the safety and tolerability of dolutegravir at 24 and 48 weeks, and to select a dose that achieves similar exposure to the dolutegravir 50 mg once daily dose in adults. This analysis included participants treated with the proposed dose of dolutegravir dispersible tablets in two stages for each of three age cohorts. This trial is registered at ClinicalTrials.gov (NCT01302847) and is ongoing.FindingsWe recruited 181 participants from April 20, 2011, to Feb 19, 2020; of these, 96 received dolutegravir dispersible tablets. This analysis included 73 (35, 48% female) participants who received the final proposed dose with median (range) age of 1 year (0·1 to 6·0), weight (minimum-maximum) of 8·5 kg (3·7 to 18·5), plasma HIV-1 RNA concentration of 4·2 log10 copies per mL (2·1 to 7·0), and CD4% of 24·0% (0·3 to 49·0); 64 (87·7%) were treatment-experienced. The selected dose within each age cohort (≥2 years to <6 years, ≥6 months to <2 years of age and ≥4 weeks to <6 months) achieved geometric mean trough (ng/mL) of 688, 1179, and 1446, and 24 h area-under-the-curve (h·mg/L) of 53, 74, and 65, respectively. No grade 3 or worse adverse events were attributed to dolutegravir.InterpretationIn this study, the proposed once daily dosing of dolutegravir dispersible tablets provided drug exposures similar to those for adults, and was safe and well tolerated. These data support the use of dolutegravir dispersible tablets as first-line or second-line treatment for infants and children aged less than 6 years living with HIV-1.FundingNational Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Mental Health, and ViiV Healthcare-GlaxoSmithKline