Drug Interaction Study With Atazanavir Administered With and Without Ritonavir and a Cytochrome P450 Substrate Rosiglitazone

NCT ID: NCT00362726

Last Updated: 2011-04-08

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2006-11-30

Brief Summary

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The purpose of this clinical research study is to assess the effect of Atazanavir 400 mg QD and Atazanavir/Ritonavir 300/100 mg QD at steady state on the single dose pharmacokinetics of RGZ in healthy subjects.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Rosiglitazone maleate

Intervention Type DRUG

Tablets, Oral, RGZ 4 mg, once daily, 1 day.

B

Group Type ACTIVE_COMPARATOR

Atazanavir Sulphate

Intervention Type DRUG

Capsules, Oral, ATV 400 mg, once daily, 5 days.

C

Group Type ACTIVE_COMPARATOR

Atazanavir Sulphate + Rosiglitazone maleate

Intervention Type DRUG

Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.

D

Group Type ACTIVE_COMPARATOR

Atazanavir Sulphate + Ritonavir

Intervention Type DRUG

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.

E

Group Type ACTIVE_COMPARATOR

Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate

Intervention Type DRUG

Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.

Interventions

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Rosiglitazone maleate

Tablets, Oral, RGZ 4 mg, once daily, 1 day.

Intervention Type DRUG

Atazanavir Sulphate

Capsules, Oral, ATV 400 mg, once daily, 5 days.

Intervention Type DRUG

Atazanavir Sulphate + Rosiglitazone maleate

Capsule, Oral, ATV 400 mg + RGZ 4 mg, once daily, 1 day.

Intervention Type DRUG

Atazanavir Sulphate + Ritonavir

Capsules, Oral, ATV 300 mg + RTV 100 mg, once daily, 14 days.

Intervention Type DRUG

Atazanavir Sulphate + Ritonavir + Rosiglitazone maleate

Capsules/Tablets, Oral, ATV 300 mg + RTV 100 mg + RGZ 4 mg, once daily, 1 day.

Intervention Type DRUG

Other Intervention Names

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Reyataz Reyataz Reyataz Reyataz

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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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AI424-106

Identifier Type: -

Identifier Source: org_study_id

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