View Clinical Trial (Medical Research Study)

Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061) - NCT00925535-06511(Clinical Trial 299069)



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City:  New Haven
State:  
CT
Zip Code: 06511
Conditions: Healthy Volunteers
Purpose: Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.
Study summary:
Criteria: Inclusion Criteria: - Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. - Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: - Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. - History of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor). - Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. - Hypersensitivity/allergic reactions to any component of the study drugs.
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Data Source: ClinicalTrials.gov
Date Processed: February 2, 2010
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