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

Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Intervention: levonorgestrel, efavirenz (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Colorado, Denver

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

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Eligibility

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

Locations and Contacts

University of Colorado Health Sciences Center, Denver, Colorado 80262, United States

The Miriam Hospital, Providence, Rhode Island 02906, United States

Additional Information

Starting date: May 2007
Last updated: July 11, 2013

Page last updated: August 23, 2015

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