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TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz

Primary Purpose

HIV Infections, Tuberculosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rifabutin
Efavirenz
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring tuberculosis, TB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily.

Sites / Locations

  • Central Arkansas Veterans Health System
  • LA County/USC Medical Center
  • University of California, San Francisco
  • Denver Department of Public Health and Hospitals
  • Washington, D.C. VAMC
  • Chicago VA Medical Center (Lakeside)
  • Hines VA Medical Center
  • Johns Hopkins University School of Medicine
  • Boston Medical Center
  • New Jersey Medical School
  • New York University School of Medicine
  • Columbia University/Presbyterian Medical Center
  • Harlem Hospital Center
  • Carolinas Medical Center
  • Duke University Medical Center
  • Nashville VA Medical Center
  • University of North Texas Health Science Center
  • Thomas Street Clinic
  • Audi L. Murphy VA Hospital
  • Seattle King County Health Department
  • University of British Columbia
  • University of Manitoba
  • Montreal Chest Institute McGill University

Outcomes

Primary Outcome Measures

Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz

Secondary Outcome Measures

*Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's
*Describe PK of efavirenz in this regimen
*Assess safety of concomitant rifabutin and efavirenz in HIV-TB

Full Information

First Posted
September 6, 2001
Last Updated
June 4, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00023413
Brief Title
TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz
Official Title
TBTC Study 23C: Intensive Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid With Daily Efavirenz in Combination With Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-infections
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study. Primary Objective: To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Tuberculosis
Keywords
tuberculosis, TB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rifabutin
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Primary Outcome Measure Information:
Title
Compare PK of rifabutin 600mg twice weekly with efavirenz 600mg daily to PK of rifabutin 300mg twice weekly without efavirenz
Secondary Outcome Measure Information:
Title
*Describe PK of rifabutin 600mg twice weekly in combination with efavirenz 600mg daily with 2 NRTI's
Title
*Describe PK of efavirenz in this regimen
Title
*Assess safety of concomitant rifabutin and efavirenz in HIV-TB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Weiner, MD
Organizational Affiliation
San Antonio VAMC, San Antonio TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Health System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
LA County/USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Denver Department of Public Health and Hospitals
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Washington, D.C. VAMC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Chicago VA Medical Center (Lakeside)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Hines VA Medical Center
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0003
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07107-3001
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University/Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
34222
Country
United States
Facility Name
Nashville VA Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107-2699
Country
United States
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Audi L. Murphy VA Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Seattle King County Health Department
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
Canada V5Z 4R4
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
CANADA R3A 1R8
Country
Canada
Facility Name
Montreal Chest Institute McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4Pq Canada
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.cdc.gov/nchstp/tb/tbtc/
Description
(Click here for more information about the Tuberculosis Trials Consortium(TBTC)

Learn more about this trial

TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz

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