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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Ritonavir
Lopinavir
Rifabutin
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antitubercular Agents

ClinicalTrials.gov processed this record on September 16, 2014