Drug Interaction - Oral Contraceptive

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Ortho Cyclen + Efavirenz; Drug: Ortho Tri-Cyclen LO; Drug: Ortho Cyclen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00399685

AI266-145

Details and patient eligibility

About

The purpose of this study is to administer a combined oral contraceptive containing ethinyl estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to assess if the concentrations of the oral contraceptives change. The safety of this treatment regimen will also be studied.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women of childbearing potential with intact ovarian function who have been on a stable method of oral contraceptives for at least 2 months prior to the start of the study.
• Documented acceptable Pap smear within 1 year of the start of the study
• BMI of 18-32 kg/m²

Exclusion criteria

• Males
• Subjects with abnormal menstrual cycle within 2 months prior to the start of the study
• History of conditions in which oral contraceptives are contraindicated
• History of migraine with focal aura
• History of uncontrolled hypertension
• Positive screening test for HIV-1,-2, HIV viral RNA, Hepatitis B surface antigen, or Hepatitis C antibody
• History of diagnosed mental illness or suicidal ideation

Trial design

28 participants in 4 patient groups

A

Active Comparator group

Treatment:

Drug: Ortho Tri-Cyclen LO

B

Active Comparator group

Treatment:

Drug: Ortho Cyclen

Drug: Ortho Cyclen

C

Active Comparator group

Treatment:

Drug: Ortho Cyclen + Efavirenz

D

Active Comparator group

Treatment:

Drug: Ortho Cyclen

Drug: Ortho Cyclen