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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Infections, Contraception, Pharmacokinetics

Intervention / Treatment
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* Drug: levonorgestrel, efavirenz


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: levonorgestrel, efavirenz<br>healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz | Drug: levonorgestrel, efavirenz<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Contraception, Antiretroviral agents, Pharmacokinetics