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

Condition(s) targeted: HIV Infections

Intervention: 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 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

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

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

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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Covance Cpu, Inc, San Diego, California 92123, United States

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: July 2006
Last updated: June 12, 2008