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

Phase 1

Completed

• Conditions: HIV Infections; Contraception; Pharmacokinetics
• Interventions: Drug: levonorgestrel, efavirenz

• Registration Number: NCT00482963
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-05
• Study First Posted: 2007-06-06
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-11
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Healthy, HIV-1 seronegative women of child-bearing age.

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Exclusion Criteria

• Current use of hormonal contraception
• Pregnancy/Breast Feeding
• Post-menopausal status
• Obesity
• Hepatitis B or C
• Psychiatric illness
• Active Substance Abuse

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States