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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00357604

Run by

Bristol-Myers Squibb

People needed

22

Starts

2006-07-01

Expected to finish

2006-11-01

Last updated by the study team

2011-04-08

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance Cpu, Inc — San Diego, California, United States

Full record on ClinicalTrials.gov

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