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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Contraceptive Agents; Contraceptives, Oral; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Fluoroquinolones; Moxifloxacin; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Norgestrel; Polyestradiol phosphate; Ritonavir

Criteria

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