Trial reportJournal of acquired immune deficiency syndromes (1999)2009
Abacavir and metabolite pharmacokinetics in HIV-1-infected children and adolescents.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 12 citations in OpenAlex.
- Population pharmacokinetics of abacavir and lamivudine in severely malnourished human immunodeficiency virus-infected children in relation to treatment outcomes.British journal of clinical pharmacology · 2019Trial
- Abacavir Drug Exposures in African Children Under 14 kg Using Pediatric Solid Fixed Dose Combinations According to World Health Organization Weight Bands.Journal of the Pediatric Infectious Diseases Society · 2023Article
- Population pharmacokinetics of abacavir in infants, toddlers and children.British journal of clinical pharmacology · 2013Article
- Molecular recognition of the antiretroviral drug abacavir: towards the development of a novel carbazole-based fluorosensor.Journal of fluorescence · 2011Article
- Pharmacokinetic optimization of antiretroviral therapy in children and adolescents.Clinical pharmacokinetics · 2011Review
- Pharmacotherapy of pediatric and adolescent HIV infection.Therapeutics and clinical risk management · 2009Article
- Abacavir pharmacokinetics during chronic therapy in HIV-1-infected adolescents and young adults.Clinical pharmacology and therapeutics · 2009Article
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 1 country.
Funding
Abstract
objectivesAbacavir (ABC) oral clearance, adjusted for body size, is approximately 2 times higher for children than adults with a corresponding difference in dose regimens. However, there are limited data available in the adolescent population. The pharmacokinetics (PKs) of ABC and primary metabolites were determined in HIV-1-infected children and adolescents to evaluate age and patient characteristics as a basis for adjusting ABC dose regimens and to assess the influence of metabolite formation on PK parameters.
methodsPediatric subjects 9-18 years of age receiving antiretroviral therapy for HIV-1 infection were stratified by Tanner stage and given a single 8 mg/kg dose of ABC oral solution. Blood samples (n = 10) were obtained over 8 hours and measured for ABC, glucuronide, and carboxylate metabolites using high-performance liquid chromatography. PK parameters for children (Tanner stages 1-2; TS1) and adolescents (Tanner stages 3-5; TS2) were compared.
resultsTwenty-five subjects were enrolled. ABC mean (range) maximum concentration (Cmax; microg/mL), area under the curve (microg.hr/mL), half-life (hours), and apparent clearance (CL/F; mL/min per kg) for TS1 and TS2 were 3.5 (1.2-5.6) vs 3.4 (1.8-5.9), 8.0 (2.1-18.6) vs 8.9 (3.1-17.2), 1.3 (0.7-2.5) vs 1.4 (0.9-1.9), and 22.1 (7.0-59.2) vs 18.4 (7.7-42.9) and not significantly different. Age, Tanner stage, and sex were not correlated with ABC clearance by univariate analysis. The ratios of metabolites to ABC area under the curve were correlated with ABC clearance as were the ratios of metabolites to ABC concentrations at the 6-hour time point.
conclusionsABC oral clearance in HIV-1-infected pediatric patients does not change during puberty, is similar to younger children, and is higher than previously published in adults. Therefore, dosing adolescents as adults should be reexamined. Intersubject PK variability is substantial and is not correlated with body size or age but more likely due to differences in metabolite formation that may be genetic in origin.
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