Drug Interaction Study

Completed · Phase 1

Conditions studied: Antivirals/HIV

In brief

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

Key facts

Study ID

NCT00646776

Run by

Bristol-Myers Squibb

People needed

85

Starts

2008-04-01

Expected to finish

2008-08-01

Last updated by the study team

2013-01-31

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bristol-Myers Squibb Clinical Pharmacology Unit — Hamilton, New Jersey, United States

Full record on ClinicalTrials.gov

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