DDI HV (ATV - Merck) - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb Merck
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00518297

Purpose

The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.

Condition	Intervention	Phase
HIV Infections	Drug: Raltegravir Drug: Atazanavir Drug: Atazanavir + Raltegravir	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir Atazanavir sulfate BMS 232632

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Official Title:	Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Safety Assessments [ Time Frame: Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge ]
Pharmacokinetic Assessments [ Time Frame: Days 5, 12, and 26 ]

Enrollment:	22
Study Start Date:	August 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Raltegravir Tablet, Oral, 400 mg, twice daily for 5 Days
2: Active Comparator	Drug: Atazanavir Capsule, Oral, 300 mg, twice daily for 7 Days
3: Active Comparator	Drug: Atazanavir + Raltegravir Capsule/Tablet, Oral, 300/400, twice daily for 14 Days

Eligibility

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

Criteria

Inclusion Criteria:

Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m²
Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test

Exclusion Criteria:

Any significant acute or chronic medical illness
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations.
Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518297

Locations

United States, New Jersey
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, United States, 08690

Sponsors and Collaborators

Bristol-Myers Squibb

Merck

Investigators

Study Director:

Bristol-Myers Squibb

More Information

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

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI424-352
Study First Received:	August 17, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00518297
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Antivirals / HIV

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome

Atazanavir
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 15, 2009