STUDY OBJECTIVE: To examine the pharmacokinetics of zidovudine during the menstrual cycle in human immunodeficiency virus- (HIV-) positive women. DESIGN: Open, unblinded study. SETTING: A women's clinic for acquired immunodeficiency syndrome (AIDS) at a large medical center. PATIENTS: HIV-positive women with a CD4+ cell count above 200/mm3, receiving long-term zidovudine therapy, with a history of regular menstrual cycles. INTERVENTIONS: All patients received a 100-mg dose of zidovudine in the fasted state on three occasions. MEASUREMENTS AND MAIN RESULTS: Zidovudine and zidovudine-glucuronide plasma concentrations were measured with radioimmunoassay to determine the pharmacokinetic characteristics during each menstrual phase. The drug's mean peak plasma concentrations (range 233-808 ng/ml) were 556 +/- 145, 385 +/- 132, and 495 +/- 143 ng/ml during the menstrual, late follicular-ovulatory, and luteal phases, respectively. Initially, plasma concentrations declined in a linear fashion from 0 to 4 hours, with a prolonged elimination phase in many patients after 4 hours. The mean zidovudine area under the curve was 886 +/- 156, 845 +/- 268, and 775 +/- 167 ng.hour/ml. The mean percentage of dose recovered was 44.2 +/- 26.0, 56.9 +/- 19.1, and 42.2 +/- 16.6, respectively. CONCLUSIONS: The pharmacokinetics of zidovudine were not different during the three phases of the menstrual cycle; however, considerable intrapatient and interpatient variability was noted for many of the values.
STUDY OBJECTIVE: To examine the pharmacokinetics of zidovudine during the menstrual cycle in human immunodeficiency virus- (HIV-) positive women. DESIGN: Open, unblinded study. SETTING: A women's clinic for acquired immunodeficiency syndrome (AIDS) at a large medical center. PATIENTS: HIV-positive women with a CD4+ cell count above 200/mm3, receiving long-term zidovudine therapy, with a history of regular menstrual cycles. INTERVENTIONS: All patients received a 100-mg dose of zidovudine in the fasted state on three occasions. MEASUREMENTS AND MAIN RESULTS:Zidovudine and zidovudine-glucuronide plasma concentrations were measured with radioimmunoassay to determine the pharmacokinetic characteristics during each menstrual phase. The drug's mean peak plasma concentrations (range 233-808 ng/ml) were 556 +/- 145, 385 +/- 132, and 495 +/- 143 ng/ml during the menstrual, late follicular-ovulatory, and luteal phases, respectively. Initially, plasma concentrations declined in a linear fashion from 0 to 4 hours, with a prolonged elimination phase in many patients after 4 hours. The mean zidovudine area under the curve was 886 +/- 156, 845 +/- 268, and 775 +/- 167 ng.hour/ml. The mean percentage of dose recovered was 44.2 +/- 26.0, 56.9 +/- 19.1, and 42.2 +/- 16.6, respectively. CONCLUSIONS: The pharmacokinetics of zidovudine were not different during the three phases of the menstrual cycle; however, considerable intrapatient and interpatient variability was noted for many of the values.
Authors: Sandi L Navarro; Yu Chen; Lin Li; Shuying S Li; Jyh-Lurn Chang; Yvonne Schwarz; Irena B King; John D Potter; Jeannette Bigler; Johanna W Lampe Journal: Drug Metab Dispos Date: 2011-06-10 Impact factor: 3.922
Authors: S C Piscitelli; M A Amatea; S Vogel; C Bechtel; J A Metcalf; J A Kovacs Journal: Antimicrob Agents Chemother Date: 1996-01 Impact factor: 5.191
Authors: Charles E Frost; John Adams; Mark Shelton; Abdel-Hameed I Mohammed Ebid; Lawrence J Gugino; Ross Hewitt; Robin Difrancesco; Elizabeth Ingalls; Stephen Cousins; J Hu; Gene D Morse Journal: Clin Drug Investig Date: 2002 Impact factor: 2.859