PMID: 9165548May 1, 1997Paper

Effects of spontaneous gastric hypoacidity on the pharmacokinetics of zidovudine and didanosine

Pharmacotherapy
M J SheltonG D Morse

Abstract

To determine the effect of spontaneous gastric hypoacidity on the pharmacokinetics of zidovudine and didanosine in subjects infected with the human immunodeficiency virus (HIV). Controlled, open-label, single-dose, pharmacokinetic study. Thirty-two asymptomatic HIV-infected subjects. Gastric pH studies were conducted in all 32 subjects, and 20 of these subjects (8 women, 12 men) were enrolled into the pharmacokinetic study. They were stratified into two groups according to fasting gastric pH: those without and with gastric hypoacidity (minimum gastric pH < 3 and > or = 3, respectively). Gastric pH was measured using the Heidelberg pH monitoring system in all subjects before and during pharmacokinetic analysis of zidovudine 100 mg or didanosine 200 mg (given as two 100-mg tablets dissolved in 6 oz water). Plasma samples were collected over 8 hours after dosing. Six (20%) of 30 subjects had a minimum gastric pH of 3 or above on at least two occasions, and the remaining 2 had variable gastric pH. Although gastric pH was unchanged during the administration of zidovudine, it increased to greater than 9 in 11 of 12 subjects with didanosine, regardless of baseline value. For both drugs, there were no statistically significant differen...Continue Reading

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