Clinical Trials

MainTitle

TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB

This study has been completed
Sponsor
Centers for Disease Control and Prevention

Collaborator
VA Office of Research and Development

Information provided by (Responsible Party)
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier
NCT00023400

First received: September 6, 2001
Last updated: September 1, 2005
Last Verified: September 2005
History of Changes
Purpose

Purpose

Primary Objective:

To define the impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on peak levels and area under the curve for rifabutin and the rifabutin metabolite, 25-O-desacetyl rifabutin when rifabutin is given at 300 mg bi-weekly as part of tuberculosis chemotherapy.

Secondary Objectives:

To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.

To evaluate the correlation between pharmacokinetic parameters of rifabutin and 25-O-desacetyl rifabutin and the occurrence of toxicity attributed to rifabutin in patients with HIV-related tuberculosis.

To define detailed pharmacokinetics of isoniazid given at 15mg/kg or 900 mg in patients with HIV-related tuberculosis.

To attempt to derive optimal sampling times for nelfinavir and rifabutin pharmacokinetic studies.

Condition Intervention Phase
HIV Infections
Tuberculosis

Drug : Nelfinavir
Drug : Rifabutin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures

  • Impact of nelfinavir (given at 1250mg bid as part of a combination antiretroviral regimen) on area under the curve for rifabutin and 25-O-desacetyl rifabutin when rifabutin is given 300 mg bi-weekly as part of tuberculosis chemotherapy.
Secondary Outcome Measures:
  • To compare the pharmacokinetics of nelfinavir given twice daily at 1250 mg bid with twice-weekly isoniazid and rifabutin to the pharmacokinetics of nelfinavir 1250 mg twice-daily in historical HIV-infected patients not receiving isoniazid and rifabutin.

Enrollment: 20
Study Start Date: February 2000
Study Completion Date: February 2002

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

  • Patients with HIV-related tuberculosis

contacts and locations

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00023400

Locations

United States, Arkansas
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States, 72205
United States, California
LA County/USC Medical Center
Los Angeles, California, United States, 90033
University of California, San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Denver Department of Public Health and Hospitals
Denver, Colorado, United States, 80204
United States, District of Columbia
Washington, D.C. VAMC
Washington, District of Columbia, United States, 20422
United States, Illinois
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, United States, 60611
Hines VA Medical Center
Hines, Illinois, United States, 60141
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287-0003
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07107-3001
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Columbia University/Presbyterian Medical Center
New York, New York, United States, 10032
Harlem Hospital Center
New York, New York, United States, 10037
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 34222
United States, Tennessee
Nashville VA Medical Center
Nashville, Tennessee, United States, 37212-2637
United States, Texas
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76107-2699
Thomas Street Clinic
Houston, Texas, United States, 77009
Audi L. Murphy VA Hospital
San Antonio, Texas, United States, 78284
United States, Washington
Seattle King County Health Department
Seattle, Washington, United States, 98104
Canada
University of British Columbia
Vancouver, British Columbia, Canada, Canada V5Z 4R4
University of Manitoba
Winnipeg, Manitoba, Canada, CANADA R3A 1R8
Montreal Chest Institute McGill University
Montreal, Quebec, Canada, H2X 2P4Pq Canada

Sponsors and Collaborators

Centers for Disease Control and Prevention
VA Office of Research and Development

Investigators

Study Chair: Debra Benator, MD Washington, D.C. VAMC
More Information

More Information

Additional Information:

(Click here for more information about the Tuberculosis Trials Consortium(TBTC)

Responsible Party: Centers for Disease Control and Prevention  
ClinicalTrials.gov Identifier: NCT00023400   History of Changes  
Other Study ID Numbers: CDC-NCHSTP-2587  
  23B  
Study First Received: September 6, 2001  
Last Updated: September 1, 2005  

Keywords provided by Centers for Disease Control and Prevention:

tuberculosis
TB

Additional relevant MeSH terms:
HIV Infections
Tuberculosis
Nelfinavir
Rifabutin

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.