We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
  • 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 ]

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
  • Kaletra
Drug: rifabutin
rifabutin capsule; see arms for intervention description
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
  • Kaletra
Drug: rifabutin
rifabutin capsule; see arms for intervention description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Daniel Cohen, MD/Study Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00743470     History of Changes
Other Study ID Numbers: M10-457
First Submitted: August 27, 2008
First Posted: August 28, 2008
Last Update Posted: November 2, 2010
Last Verified: September 2010

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
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antitubercular Agents


To Top