Back to resultsA Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
Primary Purpose
HIV, Tuberculosis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lopinavir/ritonavir
rifabutin
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring HIV co-infected with tuberculosis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Site Reference ID/Investigator# 11441
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A, B
C
Arm Description
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.
Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
Outcomes
Primary Outcome Measures
Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00743470
Brief Title
A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
Official Title
A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Tuberculosis
Keywords
HIV co-infected with tuberculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A, B
Arm Type
Experimental
Arm Description
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.
Arm Title
C
Arm Type
Experimental
Arm Description
Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir
Other Intervention Name(s)
ABT-378, Kaletra
Intervention Description
lopinavir/ritonavir tablet; see arm for intervention description
Intervention Type
Drug
Intervention Name(s)
rifabutin
Intervention Description
rifabutin capsule; see arms for intervention description
Primary Outcome Measure Information:
Title
Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.
Time Frame
Approximately 0.5 - 1 month
Title
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
Time Frame
Approximately 0.5 - 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Nilius, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 11441
City
Waukegan
State/Province
Illinois
ZIP/Postal Code
60085
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
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