Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women
Status:
Withdrawn
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
Data suggests 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 yet been determined. The primary purpose of this
study is to examine whether a 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 HIV infected women. The antiretroviral drugs
atazanavir, ritonavir, tenofovir and emtricitabine will be studied.
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)