A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
This study has been completed.
Sponsor:
University of Colorado, Denver
Collaborators:
The Miriam Hospital
University of Washington
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00482963
First received: June 5, 2007
Last updated: July 11, 2013
Last verified: July 2013
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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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz [ Time Frame: 12 hour pharmacokinetic study ] [ Designated as safety issue: No ]
- Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- Changes in liver function tests before and during efavirenz [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
- The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls [ Time Frame: 12 hour pharmacokinetic study ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | May 2007 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: levonorgestrel, efavirenz
healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz
|
Drug: levonorgestrel, 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.
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482963
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00482963 History of Changes |
| Other Study ID Numbers: | 06-1178 |
| Study First Received: | June 5, 2007 |
| Last Updated: | July 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
HIV Contraception Antiretroviral agents Pharmacokinetics |
Additional relevant MeSH terms:
|
Efavirenz Levonorgestrel Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Contraceptive Agents Contraceptive Agents, Female Contraceptives, Oral Contraceptives, Oral, Synthetic |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Reverse Transcriptase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015