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Atazanavir Twice Daily

NCT ID: NCT00357721

Last Updated: 2011-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections Protease Inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

Atazanavir Sulphate

Intervention Type DRUG

Capsules, Oral, 200 mg, twice daily, 7 days.

A2

Group Type ACTIVE_COMPARATOR

Atazanavir Sulphate

Intervention Type DRUG

Capsules, Oral, 300 mg, twice daily, 8 days.

A3

Group Type ACTIVE_COMPARATOR

Atazanavir Sulphate

Intervention Type DRUG

Capsules, Oral, 400 mg, twice daily, 9 days.

Interventions

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Atazanavir Sulphate

Capsules, Oral, 200 mg, twice daily, 7 days.

Intervention Type DRUG

Atazanavir Sulphate

Capsules, Oral, 300 mg, twice daily, 8 days.

Intervention Type DRUG

Atazanavir Sulphate

Capsules, Oral, 400 mg, twice daily, 9 days.

Intervention Type DRUG

Other Intervention Names

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Reyataz Reyataz Reyataz

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Hamilton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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AI424-286

Identifier Type: -

Identifier Source: org_study_id

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