Dose Finding Confirmation of Atazanavir With Ritonavir and Efavirenz (ATV/RTV + EFV) in Healthy Subjects - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00357188

Purpose

The purpose of this study is to assess the exposure of Atazanavir 400 mg with Ritonavir 100 mg and with Efavirenz 600 mg compared to Atazanavir 300 mg with 100 mg without Efavirenz in Healthy Subjects

Condition	Intervention	Phase
HIV Infections Protease Inhibitor	Drug: Atazanavir Sulphate + Ritonavir Drug: Atazanavir Sulphate + Ritonavir + Efavirenz	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz Ritonavir Atazanavir sulfate BMS 232632

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Official Title:	Open-Label, Multiple Dose Study to Determine the Relative Bioavailability of Atazanavir (ATV) 400 mg Administered With Ritonavir (RTV) and Efavirenz (EFV) Compared to Atazanavir 300 mg Administered With Ritonavir Alone in Healthy Subjects

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To assess the comparability of atazanavir exposure when dosed in the evening as atazanavir 400 mg with ritonavir 100 mg and with efavirenz 600 mg relative to ATV 300 mg and RTV 100 mg alone in healthy subjects

Secondary Outcome Measures:

To assess the PK of EFV when coadministered with ATV 400 mg and RTV 100 mg in the evening
To assess the PK of RTV when dosed as ATV 400 mg with RTV 100 mg and with EFV 600 mg in the evening relative to ATV 300 mg with RTV 100 mg alone
To assess the safety and tolerability of ATV and RTV alone and when coadministered with EFV in the evening in healthy subjects

Estimated Enrollment:	22
Study Start Date:	July 2006

Arms	Assigned Interventions
A: Active Comparator	Drug: Atazanavir Sulphate + Ritonavir Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 10 days.
B: Active Comparator	Drug: Atazanavir Sulphate + Ritonavir + Efavirenz Capsules/Tablets, oral, ATV 400 mg + RTV 100 mg + EFV 600 mg, once daily, 14 days.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

BMI 18-30
Men and women who are not of childbearing potential, ages 18-50 years, inclusive

Exclusion Criteria:

History of seizures or other central nervous system disorders (including migraine headaches)
history of diagnosed mental illness or suicidal tendencies
positive screening for Hep B surface antigen
Hep C antibody
HIV-1, -2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357188

Locations

United States, New Jersey
Local Institution
Hamilton, New Jersey, United States

Sponsors and Collaborators

Bristol-Myers Squibb

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 www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	AI424-283
Study First Received:	July 26, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00357188
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Efavirenz
Signs and Symptoms
Sexually Transmitted Diseases, Viral
Ritonavir
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
Reverse Transcriptase Inhibitors
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009