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

September 1, 2005 updated by: Centers for Disease Control and Prevention

TBTC Study 23B:Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Patients with HIV-related tuberculosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

US Department of Veterans Affairs

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Study Completion

February 1, 2002

Study Registration Dates

First Submitted

September 6, 2001

First Submitted That Met QC Criteria

September 8, 2001

First Posted (Estimate)

September 10, 2001

Study Record Updates

Last Update Posted (Estimate)

September 5, 2005

Last Update Submitted That Met QC Criteria

September 1, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCHSTP-2587
  • 23B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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