Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight
Status:
Completed
Trial end date:
2003-06-01
Target enrollment:
Participant gender:
Summary
This study would be a prospective cohort study, stratified by weight. Patients who are stable
on nevirapine for at least 3 months prior to study entry, but no more than 1year will be
recruited. For 1 week, subjects will take their morning dose of nevirapine in the clinic (and
be observed taking it), and given their evening dose to take at home. Subjects will need to
record the date and time they take their evening dose. At the end of the week, the subjects
will be sequestered at the clinic for blood draws for a 12hr pharmacokinetic sampling. They
will not be brought back in at 24hrs as they will need to be redosed after 12hrs. They will
have Liver Function Tests (LFT's) and other labs drawn at study entry, and one month after
the end of study. Pharmacokinetic levels will be analyzed using standard mathematical models,
and Area Under the Curve (AUC), Maximum concentration (Cmax), and Minimum Concentration
(Cmin) will be compared between groups.