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

Bristol-Myers Squibb22 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)DRUG

Tablets, Oral, 35 mcg of EE + 0.18/0.215/0.25 mg of NGM, once daily, 28 days.

Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 daysDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance Cpu, Inc

San Diego, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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