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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-12-31

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.

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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.

Conditions

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HIV Infections Contraception Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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levonorgestrel, efavirenz

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

Group Type EXPERIMENTAL

levonorgestrel, efavirenz

Intervention Type DRUG

Interventions

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levonorgestrel, efavirenz

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes