Status:
COMPLETED
Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00925535
Start Date
May 1 2010
End Date
August 1 2010
Last Update
September 21 2010
Active Locations (1)
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1
Pfizer Investigational Site
Singapore, Singapore, 188770