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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT00482963

Collaborator

The Miriam Hospital (Other), University of Washington (Other), Bristol-Myers Squibb (Industry)

Enrollment

Locations

Arm

19.1

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Contraception Pharmacokinetics	Drug: levonorgestrel, efavirenz	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: levonorgestrel, efavirenz healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz	Drug: levonorgestrel, efavirenz

Arm

Intervention/Treatment

Experimental: levonorgestrel, efavirenz

healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz

Drug: levonorgestrel, efavirenz

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]