Skip to main content
OpenTrials
Completed

NCT Number: NCT00482963

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Contraception Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pharmacokinetics RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Health Sciences Center, Denver, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levonorgestrel, efavirenz

Drug

Primary outcomes

  1. 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 outcomes

  1. Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz

    Time frame: 12 hour pharmacokinetic study

  2. Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz

    Time frame: 3 weeks

  3. Changes in liver function tests before and during efavirenz

    Time frame: 3 weeks

  4. The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls

    Time frame: 12 hour pharmacokinetic study

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Bristol-Myers Squibb
  • The Miriam Hospital
  • University of Washington

Registry information

Official study title

A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 6, 2007
Registry last updated
Jul 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.