Trial reportAntimicrobial agents and chemotherapy2011
Plasma and intracellular population pharmacokinetic analysis of tenofovir in HIV-1-infected patients.
Trial report in Antimicrobial agents and chemotherapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 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
56 citing papers in PubMed.
- Population pharmacokinetics of tenofovir given as either tenofovir disoproxil fumarate or tenofovir alafenamide in an African population.CPT: pharmacometrics & systems pharmacology · 2023Trial
- Pharmacokinetics of Ruxolitinib in HIV Suppressed Individuals on Antiretroviral Agent Therapy from the ACTG A5336 Study.Journal of clinical pharmacology · 2021Trial
- Individualized Adherence Benchmarks for HIV Pre-Exposure Prophylaxis.AIDS research and human retroviruses · 2021Trial
- Inhibitory Effects of Probenecid on Pharmacokinetics of Tenofovir Disoproxil Fumarate and Emtricitabine for On-Demand HIV Preexposure Prophylaxis.Clinical pharmacology and therapeutics · 2020Trial
- Race/Ethnicity and Protease Inhibitor Use Influence Plasma Tenofovir Exposure in Adults Living with HIV-1 in AIDS Clinical Trials Group Study A5202.Antimicrobial agents and chemotherapy · 2019Trial
- Effects of sofosbuvir-based hepatitis C treatment on the pharmacokinetics of tenofovir in HIV/HCV-coinfected individuals receiving tenofovir disoproxil fumarate.The Journal of antimicrobial chemotherapy · 2018Trial
- Population Pharmacokinetics of Tenofovir in HIV-1-Uninfected Members of Serodiscordant Couples and Effect of Dose Reporting Methods.Antimicrobial agents and chemotherapy · 2016Trial
- Plasma Tenofovir, Emtricitabine, and Rilpivirine and Intracellular Tenofovir Diphosphate and Emtricitabine Triphosphate Pharmacokinetics following Drug Intake Cessation.Antimicrobial agents and chemotherapy · 2015Trial
- Genomewide association study of tenofovir pharmacokinetics and creatinine clearance in AIDS Clinical Trials Group protocol A5202.Pharmacogenetics and genomics · 2015Trial
- Population pharmacokinetics of tenofovir and tenofovir-diphosphate in healthy women.Journal of clinical pharmacology · 2015Trial
- Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies.Journal of clinical pharmacology · 2014Trial
- Biphasic elimination of tenofovir diphosphate and nonlinear pharmacokinetics of zidovudine triphosphate in a microdosing study.Journal of acquired immune deficiency syndromes (1999) · 2012Trial
- Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men.Science translational medicine · 2012Trial
- Perturbation of metabolic pathways associated with exposure of human renal proximal tubular cells to nephrotoxic pollutants and drugs.Toxicology · 2026Article
- Clarifying residual drug effects and subgroup outcomes in TDF-to-BSV switch trials: Letter to the editor on "Switching to besifovir in patients with chronic hepatitis B receiving tenofovir disoproxil fumarate: A randomized trial".Clinical and molecular hepatology · 2026Article
- Pharmacokinetics of dolutegravir, tenofovir and lamivudine during venous-venous extracorporeal membrane oxygenation (VV-ECMO): A case report.British journal of clinical pharmacology · 2026Article
- Development of a Semi-Mechanistic Population Pharmacokinetic Model for Predicting Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide Exposure in Plasma and Cellular Matrices During Pregnancy and Postpartum.Clinical pharmacokinetics · 2026Article
- HIV Pharmacology Data Repository: Setting the New Information-Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies.Clinical pharmacology and therapeutics · 2025Review
- A multicompartment population PK model to predict tenofovir and emtricitabine mucosal tissue concentrations for HIV prevention.CPT: pharmacometrics & systems pharmacology · 2023Article
- Antivirals for prevention of hepatitis B virus mother-to-child transmission in human immunodeficiency virus positive pregnant women co-infected with hepatitis B virus.The Cochrane database of systematic reviews · 2023Review
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
The relationships among the dose of tenofovir disoproxil fumarate (TDF), tenofovir (TFV) plasma concentrations, and intracellular TFV diphosphate (TFV-DP) concentrations are poorly understood. Our objective was to characterize TFV and TFV-DP relationships. Data were pooled from two studies in HIV-infected persons (n = 55) on stable antiretroviral therapy. TFV and TFV-DP were measured with validated liquid chromatography/tandem mass spectrometry (LC/MS/MS) methods. Nonlinear mixed effects modeling (NONMEM 7) was used to develop the population model and explore the influence of covariates on TFV. A sequential analysis approach was utilized. A two-compartment model with first-order absorption best described TFV PK (FOCEI). An indirect stimulation of response model best described TFV-DP, where formation of TFV-DP was driven by plasma TFV concentration. Final plasma population estimates were as follows: absorption rate constant, 1.03 h(-1); apparent clearance (CL/F), 42 liters/h (33.5% interindividual variability [IIV]); intercompartment clearance, 181 liters/h; apparent central distribution volume (Vc/F), 273 liters (64.8% IIV); and apparent peripheral distribution volume (Vp/F), 440 liters (46.5% IIV). Creatinine clearance was the most significant covariate on CL/F and Vc/F. The correlation between CL/F and Vc/F was 0.553. The indirect response model for TFV-DP resulted in estimates of the maximal intracellular concentration (E(max)), the TFV concentration producing 50% of E(max) (EC(50)), and the intracellular elimination rate constant (k(out)) of 300 fmol/10(6) cells (82% IIV), 100 ng/ml (106% IIV), and 0.008 h(-1), respectively. The estimated k(out) gave an 87-h TFV-DP half-life. A predictive check assessment indicated satisfactory model performance. This model links formation of TFV-DP with plasma TFV concentrations and should facilitate more informed investigations of TFV clinical pharmacology.
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