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Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients

NCT ID: NCT00384904

Last Updated: 2010-02-05

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this clinical research study is to assess the effect of Famotidine given twice daily on Atazanavir administered with Ritonavir in HIV-Infected 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

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A1

Group Type NO_INTERVENTION

Atazanavir/Ritonavir

Intervention Type DRUG

Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.

A2

Group Type EXPERIMENTAL

Atazanavir/Ritonavir + Famotidine

Intervention Type DRUG

Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.

A3

Group Type EXPERIMENTAL

Atazanavir/Ritonavir + Famotidine

Intervention Type DRUG

Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.

B1

Group Type NO_INTERVENTION

Atazanavir/Ritonavir

Intervention Type DRUG

Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.

B2

Group Type EXPERIMENTAL

Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine

Intervention Type DRUG

Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.

B3

Group Type EXPERIMENTAL

Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine

Intervention Type DRUG

Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.

Interventions

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Atazanavir/Ritonavir

Capsules/capsules, Oral, 300/100 mg, Once daily, 10 days.

Intervention Type DRUG

Atazanavir/Ritonavir + Famotidine

Capsules/capsules + Tablets, Oral, 300/100 mg + 40 mg, Once daily + Twice daily, 7 days.

Intervention Type DRUG

Atazanavir/Ritonavir + Famotidine

Capsules/capsules + Tablets, Oral, 300/100 mg + 20 mg, Once daily + Twice daily, 7 days.

Intervention Type DRUG

Atazanavir/Ritonavir

Capsules/capsules + Tablets, Oral, 300/100 mg, Once daily, 10 days.

Intervention Type DRUG

Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine

Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 40 mg, Once daily + Twice daily, 7 days.

Intervention Type DRUG

Atazanavir/Ritonavir + Tenofovir Disproxil Fumrarate + Famotidine

Capsules/capsules + Tablets + Tablets, Oral, 300/100 mg + 300 mg + 20 mg, Once daily + Twice daily, 7 days.

Intervention Type DRUG

Other Intervention Names

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Reyataz Reyataz Reyataz Reyataz Reyataz Reyataz

Eligibility Criteria

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Inclusion Criteria

* HIV-infected male and female subjects between the ages of 18 to 65 years old with a BMI 18 to 35 kg/m²
* Prior to enrollment subjects must be currently receiving Atazanavir/Ritonavir plus at least 2 NRTIs, must have plasma HIV RNA \<400 copies/mL and have CD4 count \>200 cells/mm³
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Garden State Infectious Disease Associates, Pa

Voorhees Township, New Jersey, United States

Site Status

Unc Center For Aids Research

Chapel Hill, North Carolina, United States

Site Status

Local Institution

Philadelphia, Pennsylvania, United States

Site Status

Local Institution

London, Greater London, United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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AI424-328

Identifier Type: -

Identifier Source: org_study_id

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