A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
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| ClinicalTrials.gov Identifier: NCT00482963 |
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Recruitment Status
:
Completed
First Posted
: June 6, 2007
Last Update Posted
: July 15, 2013
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Sponsor:
University of Colorado, Denver
Collaborators:
The Miriam Hospital
University of Washington
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Colorado, Denver
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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 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: levonorgestrel, efavirenz
healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz
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Drug: levonorgestrel, efavirenz |
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 ]
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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
Information from the National Library of Medicine
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 |
| 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:
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HIV Contraception Antiretroviral agents Pharmacokinetics |
Additional relevant MeSH terms:
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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 |