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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2007 by University of Colorado, Denver. Recruitment status was Recruiting

First Received on June 5, 2007. No Changes Posted

Sponsor:	University of Colorado, Denver
Collaborators:	The Miriam Hospital University of Washington Bristol-Myers Squibb
Information provided by:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00482963

Purpose

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	Intervention	Phase
HIV Infections Contraception Pharmacokinetics	Drug: levonorgestrel, efavirenz	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Birth Control Drug Reactions HIV/AIDS

Drug Information available for: Efavirenz Levonorgestrel

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:

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:

Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz [ Time Frame: 12 hour pharmacokinetic study ]
Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz [ Time Frame: 3 weeks ]
Changes in liver function tests before and during efavirenz [ Time Frame: 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 ]

Estimated Enrollment:	24
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482963

Locations

United States, Colorado
University of Colorado Health Sciences Center	Recruiting
Denver, Colorado, United States, 80262
Contact: Monica L Carten, MD 720-848-0819 monica.carten@uchsc.edu
Principal Investigator: Monica L Carten, MD
Sub-Investigator: Stephanie Teal, MD, MPH
United States, Rhode Island
The Miriam Hospital	Recruiting
Providence, Rhode Island, United States, 02906
Contact: Deborah K Perez 401-793-4632 dperez@lifespan.org
Principal Investigator: Awewura Kwara, MD
Sub-Investigator: Susan Cu-Uvin, MD

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00482963 History of Changes
Other Study ID Numbers:	06-1178
Study First Received:	June 5, 2007
Last Updated:	June 5, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:

HIV
Contraception
Antiretroviral agents
Pharmacokinetics

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Emergencies
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Disease Attributes
Pathologic Processes
Levonorgestrel

Efavirenz
Anti-Retroviral Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents

ClinicalTrials.gov processed this record on February 09, 2012