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

Tracking Information

First Received Date ^ICMJE

July 26, 2006

Last Updated Date

June 27, 2008

Start Date ^ICMJE

July 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To determine the effect of coadministration of atazanavir 300 mg and ritonavir 100 mg on the pharmacokinetics of ethinyl estradiol.

Change History

Complete list of historical versions of study NCT00357604 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To determine the effect of the coadministration of atazanavir 300 mg and ritonavir 100 mg on the PK of 17-deacetyl norgestimate
To assess the safety of atazanavir 300 mg and ritonavir 100 mg coadministered with the oral contraceptive Ortho Tri-Cyclen LO
To characterize the PK of atazanavir and ritonavir during coadministration with Ortho Tri-Cyclen LO

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: 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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00357604

Responsible Party

Study ID Numbers ^ICMJE

AI424-285

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP