Trial reportBritish journal of clinical pharmacology2005
Population pharmacokinetic analysis for nelfinavir and its metabolite M8 in virologically controlled HIV-infected patients on HAART.
Trial report in British journal of clinical pharmacology, 2005. 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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Who cites it
10 citing papers in PubMed.
- Population pharmacokinetic analysis of lamivudine, stavudine and zidovudine in controlled HIV-infected patients on HAART.European journal of clinical pharmacology · 2007Trial
- Disease-Drug-Drug Interaction of Imatinib in COVID-19 ARDS: A Pooled Population Pharmacokinetic Analysis.CPT: pharmacometrics & systems pharmacology · 2025Article
- Population Pharmacokinetic Model for Tramadol and O-desmethyltramadol in Older Patients.European journal of drug metabolism and pharmacokinetics · 2022Article
- Nanotechnology Based Repositioning of an Anti-Viral Drug for Non-Small Cell Lung Cancer (NSCLC).Pharmaceutical research · 2020Article
- Abacavir Exposure in Children Cotreated for Tuberculosis with Rifampin and Superboosted Lopinavir-Ritonavir.Antimicrobial agents and chemotherapy · 2020Article
- [Management of chronic pain using extended release tilidine : Quality of life and implication of comedication on tilidine metabolism].Schmerz (Berlin, Germany) · 2017Observational
- Clinical pharmacokinetics of antiretroviral drugs in older persons.Expert opinion on drug metabolism & toxicology · 2013Review
- Development of a complex parent-metabolite joint population pharmacokinetic model.The AAPS journal · 2011Article
- Effect of CYP2C19 polymorphism on nelfinavir to M8 biotransformation in HIV patients.British journal of clinical pharmacology · 2008Article
- Pharmacokinetic modelling of the placental transfer of nelfinavir and its M8 metabolite: a population study using 75 maternal-cord plasma samples.British journal of clinical pharmacology · 2007Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo describe the pharmacokinetics of nelfinavir and its main metabolite M8 in HIV-infected patients with a sustained virological response, to characterize the effect of covariates and to estimate inter- and intra-individual variability in the pharmacokinetics.
methodsThree hundred and twenty concentrations of both nelfinavir and M8 were measured in 46 patients enrolled in the COPHAR 1-ANRS 102 study. Blood samples were taken at a first visit (one sample before drug administration and four samples at fixed times after) and at a second visit 1 to 3 months later (one before and one 3 h after drug administration). The data from both visits on nelfinavir and M8 were modelled jointly in all patients using a population approach.
resultsA one-compartment model with first-order absorption and elimination best described nelfinavir data, with an additional compartment incorporating a first order rate-constant describing the metabolism of the drug to M8. For nelfinavir, the apparent volume of distribution (V/F ) (95% confidence interval for the mean), was 309 l (185, 516), the absorption rate constant (k(a)) was 0.4 h(-1) (0.2, 0.8), and the apparent clearance (CL/F ) was 37.3 l h(-1) (32, 44). For M8, V(m) /(Fk(m)) and CL(m)/(Fk(m)) were 866 l h(-1) (351, 2161) and 1670 l (965, 2894), respectively. The interindividual variabilities were 34.9%, 34.3% and 62.2% for V/F, CL/F and CL(m)/(Fk(m)), respectively. The interoccasion variability was 27.8% for CL/F. The mean half-lives were 05.38 h and 00.44 h for nelfinavir and M8, respectively. Significant but opposite effects of comedication with zidovudine were found on nelfinavir CL/F and M8 CL(m)/(Fk(m)), but they were not considered to be clinically relevant.
conclusionsA joint model was found to describe adequately nelfinavir and M8 concentrations and was used to estimate pharmacokinetic parameters for M8. The model can be used to build reference pharmacokinetic profiles for therapeutic drug monitoring of the drug.
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