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

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days; Drug: Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)

• Registration Number: NCT00357604
• Lead Sponsor: Bristol-Myers Squibb

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 if the concentrations of the oral contraceptive change. The safety of this treatment regimen will also be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2008-06
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2	Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days	-
A1	Ortho Tri-Cyclen (ethinyl estradiol + norgestimate)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To characterize the PK of atazanavir and ritonavir during co-administration with Ortho Tri-Cyclen LO
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

Trial Locations

Locations (1)

Covance Cpu, Inc; 🇺🇸 San Diego, California, United States