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Atazanavir Twice Daily

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ClinicalTrials.gov Identifier: NCT00357721
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : April 6, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Protease Inhibitor Drug: Atazanavir Sulphate Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
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
Study Start Date : June 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Assess the dose proportionality and the diurnal variation in the PK of atazanavir given BID
  2. Assess the effect of atazanavir BID on bilirubin values and explore the relationship between bilirubin and atazanavir dose level/exposure by UGT1A1 genetic isoform
  3. Assess the effect of atazanavir BID on metabolic parameters
  4. Assess the safety and tolerability of atazanavir when administered BID

Eligibility Criteria
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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
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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
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Additional Information:
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 Posted: July 27, 2006    Key Record Dates
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