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

Condition(s) targeted: HIV Infections; Contraception; Pharmacokinetics

Intervention: levonorgestrel, efavirenz (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Colorado at Denver and Health Sciences Center

Official(s) and/or principal investigator(s):
Monica L Carten, MD, Principal Investigator, Affiliation: University of Colorado at Denver and Health Sciences Center

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome: The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz

Secondary outcome:

Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz

Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz

Changes in liver function tests before and during efavirenz

The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

University of Colorado Health Sciences Center, Denver, Colorado 80262, United States; Recruiting
Monica L Carten, MD, Phone: 720-848-0819, Email: monica.carten@uchsc.edu
Monica L Carten, MD, Principal Investigator
Stephanie Teal, MD, MPH, Sub-Investigator

The Miriam Hospital, Providence, Rhode Island 02906, United States; Recruiting
Deborah K Perez, Phone: 401-793-4632, Email: dperez@lifespan.org
Awewura Kwara, MD, Principal Investigator
Susan Cu-Uvin, MD, Sub-Investigator

Starting date: May 2007
Ending date: May 2008
Last updated: June 5, 2007