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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00357604

Purpose

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.

Condition	Intervention	Phase
HIV Infections	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	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Norgestimate Depogen Estradiol dipropionate Moxifloxacin Ritonavir Moxifloxacin hydrochloride BMS 232632 Atazanavir sulfate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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

Secondary Outcome 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

Estimated Enrollment:	22
Study Start Date:	July 2006

Arms	Assigned Interventions
A1: Active Comparator	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.
A2: Experimental	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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357604

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

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

No publications provided

Study ID Numbers:	AI424-285
Study First Received:	July 26, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00357604 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

HIV
Protease Inhibitor

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Healthy
Estradiol 17 beta-cypionate
Hormones
Anti-Retroviral Agents
Moxifloxacin
Estradiol 3-benzoate
Polyestradiol phosphate
Retroviridae Infections

HIV Protease Inhibitors
Estrogens
Anti-HIV Agents
Benzoates
Acquired Immunodeficiency Syndrome
Ethinyl Estradiol
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes
Estradiol
Protease Inhibitors
Virus Diseases
Contraceptives, Oral, Combined
Norgestimate
Norgestrel

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents
Physiological Effects of Drugs
Estradiol valerate
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Reproductive Control Agents
Estradiol 17 beta-cypionate
Infection
Hormones
Anti-Retroviral Agents

Moxifloxacin
Therapeutic Uses
Estradiol 3-benzoate
Contraceptives, Oral, Synthetic
Polyestradiol phosphate
Retroviridae Infections
HIV Protease Inhibitors
Estrogens
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Ethinyl Estradiol
Enzyme Inhibitors
Atazanavir

ClinicalTrials.gov processed this record on May 07, 2009