Drug Interaction Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Antivirals/HIV

Treatments: Drug: Rifabutin; Drug: Rifabutin + Atazanavir + Ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646776

AI424-360

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

A

Active Comparator group

Treatment:

Drug: Rifabutin

B

Active Comparator group

Treatment:

Drug: Rifabutin + Atazanavir + Ritonavir