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
Recruitment status was Recruiting
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
First received: June 5, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
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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 1 |
| 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:
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 |
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 May 22, 2013