A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
NCT ID: NCT00743470
Last Updated: 2010-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
15 participants
INTERVENTIONAL
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A, B
Group 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
lopinavir/ritonavir
lopinavir/ritonavir tablet; see arm for intervention description
rifabutin
rifabutin capsule; see arms for intervention description
C
Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
lopinavir/ritonavir
lopinavir/ritonavir tablet; see arm for intervention description
rifabutin
rifabutin capsule; see arms for intervention description
Interventions
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lopinavir/ritonavir
lopinavir/ritonavir tablet; see arm for intervention description
rifabutin
rifabutin capsule; see arms for intervention description
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Angela Nilius, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 11441
Waukegan, Illinois, United States
Countries
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Other Identifiers
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M10-457
Identifier Type: -
Identifier Source: org_study_id