Trial reportAntimicrobial agents and chemotherapy2001
Determination of dosing guidelines for stavudine (2',3'-didehydro-3'-deoxythymidine) in children with human immunodeficiency virus infection.
Trial report in Antimicrobial agents and chemotherapy, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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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.
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Who cites it
10 citing papers in PubMed.
- A chewable pediatric fixed-dose combination tablet of stavudine, lamivudine, and nevirapine: pharmacokinetics and safety compared with the individual liquid formulations in human immunodeficiency virus-infected children in Thailand.The Pediatric infectious disease journal · 2010Trial
- Can We Improve Stavudine's Safety Profile in Children? Pharmacokinetics of Intracellular Stavudine Triphosphate with Reduced Dosing.Antimicrobial agents and chemotherapy · 2018Article
- Antiretroviral therapy during the neonatal period.Southern African journal of HIV medicine · 2015Article
- Estimation of intracellular concentration of stavudine triphosphate in HIV-infected children given a reduced dose of 0.5 milligrams per kilogram twice daily.Antimicrobial agents and chemotherapy · 2014Article
- High prevalence of lipoatrophy in pre-pubertal South African children on antiretroviral therapy: a cross-sectional study.BMC pediatrics · 2012Article
- Stavudine concentrations in women receiving postpartum antiretroviral treatment and their breastfeeding infants.Journal of acquired immune deficiency syndromes (1999) · 2012Article
- LIPODYSTROPHY SYNDROME IN HIV-INFECTED CHILDREN ON HAART.Southern African journal of HIV medicine · 2009Article
- Age-related differences in the pharmacokinetics of stavudine in 272 children from birth to 16 years: a population analysis.British journal of clinical pharmacology · 2007Article
- Nucleoside and nucleotide reverse transcriptase inhibitors in children.Clinical drug investigation · 2007Review
- Pharmacokinetics of antiretroviral therapy in HIV-1-infected children.Clinical pharmacokinetics · 2005Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The results of the development of dosing guidelines for stavudine in human immunodeficiency virus (HIV)-infected children are summarized. Included in the integrated analyses were 21 and 33 HIV-infected pediatric and adult patients, respectively, from three phase I-II studies. Data for 21 children and 18 adults who received intravenous doses of 0.125 to 2 and 0.5 to 1 mg/kg of body weight, respectively, were used for the determination of dosing guidelines; exposure data for 16 children and 15 adults who received oral doses of 1 to 2 and 0.5 to 1 mg/kg/day, respectively, were used to validate the dosing recommendations for children. Significant relationships were observed between total body clearance (in milliliters per minute) in children and adults combined and demographic parameters of age, body weight, and body surface area (R(2) = 0.77 to 0.80; P = 0.0001). Models of approximated pediatric dose based on clearance values and direct adult exposure yielded a stavudine dosage of 2 mg/kg/day for children of < or =30 kg of body weight and 1 mg/kg/day (adult dose) for children of >30 kg of body weight.
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