ArticleThe Pediatric infectious disease journal2011
Nelfinavir and Lamivudine pharmacokinetics during the first two weeks of life.
Article in The Pediatric infectious disease journal, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00099359 (Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission), which is not on this map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Phase III Randomized Trial of the Safety and Efficacy of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV-1 Transmission
Who cites it
11 citing papers in PubMed, 28 citations in OpenAlex.
- Preventive and therapeutic benefits of nelfinavir in rhesus macaques and human beings infected with SARS-CoV-2.Signal transduction and targeted therapy · 2023Trial
- Dose evaluation of lamivudine in human immunodeficiency virus-infected children aged 5 months to 18 years based on a population pharmacokinetic analysis.British journal of clinical pharmacology · 2017Trial
- Three postpartum antiretroviral regimens to prevent intrapartum HIV infection.The New England journal of medicine · 2012Trial
- Lamivudine dosing for preterm infants exposed to HIV: a population pharmacokinetic modelling and simulation study.The Journal of antimicrobial chemotherapy · 2024Article
- Serious adverse events are uncommon with combination neonatal antiretroviral prophylaxis: a retrospective case review.PloS one · 2015Article
- The last and first frontier--emerging challenges for HIV treatment and prevention in the first week of life with emphasis on premature and low birth weight infants.Journal of the International AIDS Society · 2015Article
- Getting to 90-90-90 in paediatric HIV: What is needed?Journal of the International AIDS Society · 2015Article
- Universal children's day--let's improve current interventions to reduce vertical transmission of HIV now.Journal of the International AIDS Society · 2014Article
- Translation of biomedical prevention strategies for HIV: prospects and pitfalls.Journal of acquired immune deficiency syndromes (1999) · 2013Review
- Pharmacotherapy of pediatric HIV infection.Pediatric clinics of North America · 2012Review
- Experience in international clinical research: the HIV Prevention Trials Network.Clinical investigation · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundThere are no previous data describing nelfinavir and lamivudine pharmacokinetics in neonates treated with weight-band dosing regimens.
designPharmacokinetic study of nelfinavir and lamivudine pharmacokinetics in infants during the first 2 weeks of life treated with weight-band dosing regimens.
methodsIntensive 12-hour pharmacokinetic profiles were performed between either days 4-7 or days 10-14 of life in 26 Brazilian infants.
resultsPharmacokinetic data were obtained from 26 infants who received median (range) per kg doses of 58.8 (48.4-79.0) mg/kg for nelfinavir and 2.0 (1.5-3.2) mg/kg for lamivudine. Median nelfinavir 12-hour AUC (AUC0-12) was 25.5 (1.7-183.5) μg*h/mL and median 12-hour concentration (C12h) was 1.09 (<0.04-14.44) μg/mL. AUC0-12 was less than 15 μg*h/mL (the 10% for adults) in 12 infants (46%). Median lamivudine AUC0-12 was 7.8 (2.7-15.6) μg*h/mL and median C12h was 0.23 (<0.04-0.74) μg/mL.
conclusions: Lamivudine pharmacokinetic parameters observed in this study were consistent with those seen in other studies of neonates. While median nelfinavir AUC and C12h in these neonates were above the exposure targets, interindividual variability in nelfinavir exposure was large and nelfinavir exposure failed to meet the exposure targets in 46% of infants.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.