Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Ortho Tri-Cyclen (ethinyl estradiol + norgestimate); Drug: Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days

Study type: Interventional

Funder types: Industry

Identifiers

NCT00357604

AI424-285

Details and patient eligibility

About

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

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 regimen of oral contraceptives for at least 2 months prior to beginning the study
• Documented acceptable Pap smear within 1 year prior to dosing
• Body mass index (BMI) 18-32 kg/m2

Exclusion criteria

• Males
• Subjects with an abnormal menstrual cycle during the 2 months prior to the start of the study or during the lead-in period (breakthrough bleeding/spotting)
• History of conditions where the use of oral contraceptives are contraindicated
• Known or suspected carcinoma or suspected estrogen dependent neoplasia
• History of migraine with focal aura
• History of uncontrolled hypertension
• Positive screening test for HIV-1, -2, HIV viral ribonucleic acid (RNA), hepatitis B surface antigen, or hepatitis C antibody

Trial design

22 participants in 2 patient groups

A1

Active Comparator group

Treatment:

Drug: Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)

A2

Experimental group

Treatment:

Drug: Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days