Back to resultsA Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
Primary Purpose
HIV Infections, Contraception, Pharmacokinetics
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
levonorgestrel, efavirenz
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, Contraception, Antiretroviral agents, Pharmacokinetics
Eligibility Criteria
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
Sites / Locations
- University of Colorado Health Sciences Center
- The Miriam Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
levonorgestrel, efavirenz
Arm Description
healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz
Outcomes
Primary Outcome Measures
The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz
Secondary Outcome Measures
Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz
Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz
Changes in liver function tests before and during efavirenz
The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls
Full Information
NCT ID
NCT00482963
First Posted
June 5, 2007
Last Updated
July 11, 2013
Sponsor
University of Colorado, Denver
Collaborators
The Miriam Hospital, University of Washington, Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00482963
Brief Title
A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
Official Title
A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
The Miriam Hospital, University of Washington, Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Contraception, Pharmacokinetics
Keywords
HIV, Contraception, Antiretroviral agents, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
levonorgestrel, efavirenz
Arm Type
Experimental
Arm Description
healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz
Intervention Type
Drug
Intervention Name(s)
levonorgestrel, efavirenz
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz
Time Frame
12 hour pharmacokinetic study
Title
Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz
Time Frame
3 weeks
Title
Changes in liver function tests before and during efavirenz
Time Frame
3 weeks
Title
The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls
Time Frame
12 hour pharmacokinetic study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica L Carten, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
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