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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 1

Conditions: Contraception; HIV Infections; Pharmacokinetics

Treatments: Drug: levonorgestrel, efavirenz

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00482963

06-1178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

levonorgestrel, efavirenz

Experimental group

Description:

healthy HIV-negative women of reproductive age were given levonorgestrel, efavirenz

Treatment:

Drug: levonorgestrel, efavirenz