Atazanavir Twice Daily

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00357721

First Posted: July 27, 2006

Last Update Posted: April 6, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Bristol-Myers Squibb

Purpose

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.

Condition	Intervention	Phase
HIV Infections Protease Inhibitor	Drug: Atazanavir Sulphate	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label)
Official Title:	Randomized, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics of Atazanavir Administered Twice-Daily in Health Subjects

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Atazanavir Atazanavir sulfate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Assess the pharmacokinetics (PK) of atazanavir administered twice-daily (BID) relative to historical data from atazanavir/ritonavir 300/100 mg, given once-daily.

Secondary Outcome Measures:

Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID
Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform
Assess the effect of atazanavir BID on metabolic parameters
Assess the safety and tolerability of atazanavir when administered BID


Estimated Enrollment:	18
Study Start Date:	June 2006
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A1	Drug: Atazanavir Sulphate Capsules, Oral, 200 mg, twice daily, 7 days. Other Name: Reyataz
Active Comparator: A2	Drug: Atazanavir Sulphate Capsules, Oral, 300 mg, twice daily, 8 days. Other Name: Reyataz
Active Comparator: A3	Drug: Atazanavir Sulphate Capsules, Oral, 400 mg, twice daily, 9 days. Other Name: Reyataz

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357721

Locations


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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	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


ClinicalTrials.gov Identifier:	NCT00357721 History of Changes
Other Study ID Numbers:	AI424-286
First Submitted:	July 25, 2006
First Posted:	July 27, 2006
Last Update Posted:	April 6, 2011
Last Verified:	April 2011

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases	Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents

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