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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743470
First Posted: August 28, 2008
Last Update Posted: November 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
August 27, 2008
August 28, 2008
November 2, 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 ]
  • 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 ]
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV
  • Tuberculosis
  • Drug: lopinavir/ritonavir
    lopinavir/ritonavir tablet; see arm for intervention description
    Other Names:
    • ABT-378
    • Kaletra
  • Drug: rifabutin
    rifabutin capsule; see arms for intervention description
  • 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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00743470
M10-457
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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