A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication



Status:Completed
Conditions:Contraception, Contraception, HIV / AIDS, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other, Reproductive
Healthy:No
Age Range:18 - 45
Updated:5/27/2013
Start Date:May 2007
End Date:May 2008

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A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz


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.

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
We found this trial at
2
sites
Providence, Rhode Island 02903
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Providence, RI
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Denver, CO
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