The purpose of this study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz.
The use of hormonal contraceptive pills in women with HIV is complex due to potential interactions between these agents and HIV medications. HIV-infected women taking efavirenz have an even greater need for effective birth control as this medication may cause severe brain damage to a developing fetus. The use of an emergency contraceptive agent in cases of unprotected sex or condom failure can prevent pregnancy. This study seeks to establish that Plan B can be used effectively and safely in women taking efavirenz.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
University of Colorado Health Sciences Center
Denver, Colorado, United States
The Miriam Hospital
Providence, Rhode Island, United States
The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz
Time frame: 12 hour pharmacokinetic study
Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz
Time frame: 12 hour pharmacokinetic study
Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz
Time frame: 3 weeks
Changes in liver function tests before and during efavirenz
Time frame: 3 weeks
The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls
Time frame: 12 hour pharmacokinetic study
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