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

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ClinicalTrials.gov Identifier: NCT00482963
Recruitment Status : Completed
First Posted : June 6, 2007
Last Update Posted : July 15, 2013
Sponsor:
Collaborators:
The Miriam Hospital
University of Washington
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Contraception Pharmacokinetics Drug: levonorgestrel, efavirenz Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz
Study Start Date : May 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: levonorgestrel, efavirenz
healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz
 Drug: levonorgestrel, efavirenz


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482963


Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
University of Colorado, Denver
The Miriam Hospital
University of Washington
Bristol-Myers Squibb
Investigators
Principal Investigator: Monica L Carten, MD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00482963     History of Changes
Other Study ID Numbers: 06-1178
First Posted: June 6, 2007    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013

Keywords provided by University of Colorado, Denver:
HIV
Contraception
Antiretroviral agents
Pharmacokinetics

Additional relevant MeSH terms:
HIV Infections
Emergencies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Disease Attributes
Pathologic Processes
Efavirenz
Levonorgestrel
Reverse Transcriptase Inhibitors
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents