Contraception, HIV Infections, Pharmacokinetics
Conditions
Keywords
HIV, Contraception, Antiretroviral agents, Pharmacokinetics
Brief summary
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.
Detailed description
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.
Interventions
DRUGlevonorgestrel, efavirenz
Sponsors
The Miriam Hospital
University of Washington
Bristol-Myers Squibb
University of Colorado, Denver
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, HIV-1 seronegative women of child-bearing age.
Exclusion criteria
* Current use of hormonal contraception * Pregnancy/Breast Feeding * Post-menopausal status * Obesity * Hepatitis B or C * Psychiatric illness * Active Substance Abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz | 12 hour pharmacokinetic study |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz | 12 hour pharmacokinetic study |
| Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz | 3 weeks |
| Changes in liver function tests before and during efavirenz | 3 weeks |
| The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls | 12 hour pharmacokinetic study |
Countries
United States
Outcome results
None listed