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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
  Purpose

The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.


Condition Intervention Phase
HIV
Tuberculosis
 Drug: lopinavir/ritonavir
Drug: rifabutin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: August 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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: C
Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743470

Locations
United States, Illinois
Site Reference ID/Investigator# 11441
Waukegan, Illinois, United States, 60085
Sponsors and Collaborators
Abbott
Investigators
Study Director: Angela Nilius, MD Abbott
  More Information

No publications provided

Responsible Party: Daniel Cohen, MD/Study Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00743470     History of Changes
Other Study ID Numbers: M10-457
Study First Received: August 27, 2008
Last Updated: October 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
HIV co-infected with tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifabutin
Lopinavir
Ritonavir
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Antibiotics, Antitubercular
Antitubercular Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on May 16, 2013