Drug Interaction Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-08-31

Brief Summary

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The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)

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Detailed Description

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Conditions

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Antivirals/HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Rifabutin

Intervention Type DRUG

Capsule, Oral, 150 mg, once daily, 11 Days

B

Group Type ACTIVE_COMPARATOR

Rifabutin + Atazanavir + Ritonavir

Intervention Type DRUG

Capsules, Oral, 18 Days

Rifabutin (150 mg, 2x/wk)

Atazanavir (300 mg, once daily)

Ritonavir (100 mg, once daily)

Interventions

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Rifabutin

Capsule, Oral, 150 mg, once daily, 11 Days

Intervention Type DRUG

Rifabutin + Atazanavir + Ritonavir

Capsules, Oral, 18 Days

Rifabutin (150 mg, 2x/wk)

Atazanavir (300 mg, once daily)

Ritonavir (100 mg, once daily)

Intervention Type DRUG

Other Intervention Names

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Reyataz

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (BMI) of 18 to 32 kg/m²
* Prior to enrollment, subjects must have physical and laboratory test findings within the normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test

Exclusion Criteria

* Any significant acute or chronic medical illness
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
* Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
* Use of any other drugs, including over-the-counter medications of herbal preparations within 1 week prior to study drug administration

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes