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A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects

This study has been terminated.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00743470
First received: August 27, 2008
Last updated: October 29, 2010
Last verified: September 2010
History of Changes

August 27, 2008
October 29, 2010
August 2008
October 2008   (final data collection date for primary outcome measure)
  • Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter. [ Time Frame: Approximately 0.5 - 1 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00743470 on ClinicalTrials.gov Archive Site
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A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects

The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Tuberculosis
  • Drug: lopinavir/ritonavir
    lopinavir/ritonavir tablet; see arm for intervention description
    Other Names:
    • ABT-378
    • lopinavir/ritonavir
    • Kaletra
  • Drug: rifabutin
    rifabutin capsule; see arms for intervention description
    Other Name: rifabutin
  • Experimental: 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.
    Interventions:
    • Drug: lopinavir/ritonavir
    • Drug: rifabutin
  • Experimental: C
    Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
    Interventions:
    • Drug: lopinavir/ritonavir
    • Drug: rifabutin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
Not Provided
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00743470
M10-457
Not Provided
Daniel Cohen, MD/Study Medical Director, Abbott
Abbott
Not Provided
Study Director: Angela Nilius, MD Abbott
Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP