Atazanavir Twice Daily

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00357721

First received: July 25, 2006

Last updated: April 5, 2011

Last verified: April 2011

History of Changes

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: 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


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	July 25, 2006
Last Updated:	April 5, 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

ClinicalTrials.gov processed this record on June 27, 2017

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