Zidovudine pharmacokinetics in HIV-positive women during different phases of the menstrual cycle.
OBJECTIVE
To examine the pharmacokinetics of zidovudine during the menstrual cycle in human immunodeficiency virus- (HIV-) positive women.


METHODS
Open, unblinded study.


METHODS
A women's clinic for acquired immunodeficiency syndrome (AIDS) at a large medical center.


METHODS
HIV-positive women with a CD4+ cell count above 200/mm3, receiving long-term zidovudine therapy, with a history of regular menstrual cycles.


METHODS
All patients received a 100-mg dose of zidovudine in the fasted state on three occasions.


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.
Cordaro
J A
JA
Center for Clinical Pharmacy Research, State University of New York, Buffalo 14215.
Morse
G D
GD
Bartos
L
L
Gugino
L J
LJ
Maliszewski
M
M
Colomaio
R
R
Shelton
M
M
O'Donnell
A
A
Hewitt
R
R
D000328:Adult; D005260:Female; D005498:Follicular Phase / Q000378:metabolism; D015658:HIV Infections / Q000378:metabolism*; D006801:Humans; D008183:Luteal Phase / Q000378:metabolism; D008597:Menstrual Cycle / Q000378:metabolism*; D015215:Zidovudine / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine
D015215:Zidovudine