ArticleClinical drug investigation2003
Effect of Food on the Steady-State Pharmacokinetics of Delavirdine in Patients with HIV Infection.
Article in Clinical drug investigation, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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.
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Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- Interactions of Antiretroviral Drugs with Food, Beverages, Dietary Supplements, and Alcohol: A Systematic Review and Meta-analyses.AIDS and behavior · 2023Pooled it
- Non-nucleoside reverse transcriptase inhibitors: a review on pharmacokinetics, pharmacodynamics, safety and tolerability.Journal of the International AIDS Society · 2013Review
- Pharmacokinetics of ritonavir and delavirdine in human immunodeficiency virus-infected patients.Antimicrobial agents and chemotherapy · 2003Article
- Multiple-Dose Pharmacokinetics of Delavirdine Mesylate and Didanosine in HIV-Infected Patients.Clinical drug investigation · 2003Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveIn a prior single-dose study that examined the effect of food on delavirdine pharmacokinetics in healthy volunteers, the absorption of delavirdine mesylate was delayed and the area under the curve was reduced by 26% in the presence of food. Since the complex, nonlinear pharmacokinetics of delavirdine do not permit a simple extrapolation of the results of a single-dose study to steady state, the present multiple-dose study was performed. PATIENTS AND STUDY
designThirteen stable patients with HIV-1 infection (two females, 11 males; CD4 count range 124-588 cells/mm(3)) completed a randomised, crossover study in which subjects received two 14-day treatments with delavirdine mesylate 400mg every 8 hours. In treatment A, all delavirdine doses were administered on an empty stomach and in treatment B were taken with food. A pharmacokinetic evaluation was performed on day 14 of each treatment period.
settingAn ambulatory AIDS research centre in an academic medical centre.
interventionsAdministration of delavirdine with and without food.
main outcome measuresPharmacokinetic parameters for delavirdine.
resultsThe maximum concentration (C(max)) [+/- standard deviation] in treatment A was 29.6 +/- 13.6muM and in treatment B it was 23.0 +/- 8.61muM (p = 0.037). The minimum concentrations (C(min)) were 9.45 +/- 6.7muM and 11.2 +/- 9.2muM, respectively (p > 0.05). The oral clearances (CL(oral)) were 17.8 +/- 41.6 L/h (treatment A) and 18.5 +/- 39.0 L/h (treatment B) [p > 0.05]. Similar patterns were observed for N-dealkylated delavirdine with a significant difference only in C(max) (4.13 vs 3.47muM [p = 0.022], treatment A vs B).
conclusionsThese findings indicated that, in contrast to the increased CL(oral) noted in a prior single-dose study, food did not have a significant effect at steady state on the area under the plasma concentration-time curve or C(min). Although C(max) was significantly lower when the drug was taken taken with food, the clinical relevance of this parameter as compared with the trough concentration is unclear since the current focus for antiretrovirals is on maintaining trough concentrations in excess of in vitro inhibitory concentrations.
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Registered trials
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