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

This study has been completed.
Sponsor:
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

June 5, 2007
July 11, 2013
May 2007
December 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00482963 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Contraception
  • Pharmacokinetics
Drug: levonorgestrel, efavirenz
Experimental: levonorgestrel, efavirenz
healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz
Intervention: Drug: levonorgestrel, efavirenz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00482963
06-1178
No
University of Colorado, Denver
University of Colorado, Denver
  • The Miriam Hospital
  • University of Washington
  • Bristol-Myers Squibb
Principal Investigator: Monica L Carten, MD University of Colorado, Denver
University of Colorado, Denver
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP