Status:
TERMINATED
A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
Lead Sponsor:
Abbott
Conditions:
HIV
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.
Eligibility Criteria
Inclusion
- Adult Male or Female 18-55 yrs.
- Subject has provided written consent.
- Subject is in general good health.
- If female, subject is postmenopausal.
- If female, subject is not pregnant and is not breast-feeding.
- Subject must use birth control methods or be surgically sterile.
Exclusion
- Subject is HAV-IgM, HBsAg or HIV Ab positive.
- Positive screen for drugs of abuse, alcohol, or smoking.
- Cannot be on any medication, including over the counter drugs.
- Cannot have previous history of alcohol or drug abuse.
- Cannot have history of any major diseases or disorders.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00743470
Start Date
August 1 2008
Last Update
November 2 2010
Active Locations (1)
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1
Site Reference ID/Investigator# 11441
Waukegan, Illinois, United States, 60085