Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in Healthy Women
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
Data suggest that women taking drugs to treat human immunodeficiency virus (HIV) have higher
amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The
reason for this higher drug exposure has not been determined. The primary purpose of this
study is to examine whether the pharmacokinetics (factors that determine the amount of drug
in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women
and ultimately result in higher amounts of drug in the body compared with men. In other
words, we plan to examine whether changes in sex hormones throughout the menstrual cycle
affect the amount of anti-HIV drugs in women. The antiretroviral drugs atazanavir, ritonavir,
tenofovir and emtricitabine will be studied. This study will be conducted in healthy women
since HIV may change the pharmacokinetics of anti-HIV drugs.
Phase:
Phase 4
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)