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Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir

NCT ID: NCT00365339

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-06-30

Brief Summary

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The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Atazanavir+Ritonavir+Tenofovir

Intervention Type DRUG

Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.

B

Group Type EXPERIMENTAL

Atazanavir+Ritonavir+Tenofovir+Famotidine

Intervention Type DRUG

Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.

C

Group Type EXPERIMENTAL

Atazanavir+Ritonavir+Tenofovir+Famotidine

Intervention Type DRUG

Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.

D

Group Type EXPERIMENTAL

Atazanavir+Ritonavir+Tenofovir+Famotidine

Intervention Type DRUG

Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.

E

Group Type EXPERIMENTAL

Atazanavir+Ritonavir+Tenofovir+Famotidine

Intervention Type DRUG

Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.

Interventions

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Atazanavir+Ritonavir+Tenofovir

Cap/Cap/Tablet, Oral, 300/100/300 mg, QAM/QAM/QAM, 10 days.

Intervention Type DRUG

Atazanavir+Ritonavir+Tenofovir+Famotidine

Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 coadmin, 7 days.

Intervention Type DRUG

Atazanavir+Ritonavir+Tenofovir+Famotidine

Cap/Cap/Tablet/Tablet, Oral, 300/100/300/20 mg, QAM/QAM/QAM/Q12 2 hr post, 7 days.

Intervention Type DRUG

Atazanavir+Ritonavir+Tenofovir+Famotidine

Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/QPM 12 hr post, 7 days.

Intervention Type DRUG

Atazanavir+Ritonavir+Tenofovir+Famotidine

Cap/Cap/Tablet/Tablet, Oral, 300/100/300/40 mg, QAM/QAM/QAM/Q12 2 hr post,7 days.

Intervention Type DRUG

Other Intervention Names

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Abilify Abilify Abilify Abilify Abilify

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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AI424-287

Identifier Type: -

Identifier Source: org_study_id

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