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

July 11, 2013 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz
Time Frame: 12 hour pharmacokinetic study
12 hour pharmacokinetic study

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz
Time Frame: 12 hour pharmacokinetic study
12 hour pharmacokinetic study
Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz
Time Frame: 3 weeks
3 weeks
Changes in liver function tests before and during efavirenz
Time Frame: 3 weeks
3 weeks
The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls
Time Frame: 12 hour pharmacokinetic study
12 hour pharmacokinetic study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Bristol-Myers Squibb
The Miriam Hospital
University of Washington

Investigators

  • Principal Investigator: Monica L Carten, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 5, 2007

First Submitted That Met QC Criteria

June 5, 2007

First Posted (Estimate)

June 6, 2007

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-1178

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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