Status:
COMPLETED
Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00357604
Start Date
July 1 2006
End Date
November 1 2006
Last Update
April 8 2011
Active Locations (1)
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1
Covance Cpu, Inc
San Diego, California, United States, 92123