Official Title: “The Effect of the Co-Administration of Atazanavir (ATV) and Ritonavir (RTV) on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects”

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.

Study Type: Interventional

Study Design: Other, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)
  • Tablets, Oral, 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 28 days.
• Drug: Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days
  • Tablets + Capsules/Capsules, Oral, (25 mcg of EE + 0.18/0.215/0.25 mg of NGM) + 300/100 mg then 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 21 days.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A1
• Experimental: A2

Primary Measures

• To determine the effect of co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol

Secondary Measures

• To determine the effect of the co-administration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics (PK) of 17-deacetyl norgestimate
• To assess the safety of atazanavir 300 mg and ritonavir 100 mg co-administered with the oral contraceptive Ortho Tri-Cyclen LO
• To characterize the PK of atazanavir and ritonavir during co-administration with Ortho Tri-Cyclen LO

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00357604

Study ID Number: AI424-285

ClinicalTrials.gov Identifier: NCT00357604

Health Authority: United States: Food and Drug Administration

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