Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women|
- PK parameters [ Time Frame: 28 days ] [ Designated as safety issue: No ]The area under the concentration time curve and minimum concentration for tenofovir, emtricitabine, atazanavir and ritonavir
Biospecimen Retention: Samples Without DNA
5 mL of plasma
|Study Start Date:||July 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
HIV infected women between 21-40 years of age, not receiving oral contraceptives.
Drug: Tenofovir, Emtricitabine, Atazanavir, Ritonavir
Women will be receiving Tenofovir 300mg, Emtricitabine 200mg, Atazanavir 300mg, Ritonavir 100mg, one dose on 2 separate visits. These medications will not be prescribed from the physician and not provided by the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394133
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|