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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482963
• Other study ID #: 06-1178
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2007
• Last updated: July 11, 2013
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: July 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Contraception
• HIV Infections
• Pharmacokinetics

Intervention

Drug:
• levonorgestrel, efavirenz

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Bristol-Myers Squibb, The Miriam Hospital, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz		12 hour pharmacokinetic study	No
Secondary	Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz		12 hour pharmacokinetic study	No
Secondary	Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz		3 weeks	Yes
Secondary	Changes in liver function tests before and during efavirenz		3 weeks	Yes
Secondary	The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls		12 hour pharmacokinetic study	No