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Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

Primary Purpose

HIV Infections, Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ethambutol hydrochloride
Isoniazid
Pyrazinamide
Pyridoxine hydrochloride
Rifampin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Tuberculosis, Isoniazid, Pyrazinamide, Pyridoxine, Rifampin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Antitubercular Agents

Eligibility Criteria

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

Inclusion Criteria You may be eligible for this study if you: Are HIV-positive and have tuberculosis. Are 13 years of age or older. Have written, informed consent of parent or guardian if you are under 18 years of age. Agree to practice abstinence or use barrier methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have any other disorder or condition which might cause study treatment to be undesirable. Are pregnant.

Sites / Locations

  • Univ of Southern California / LA County USC Med Ctr
  • Harbor UCLA Med Ctr
  • University of Miami (Pediatric)
  • Emory Univ
  • Queens Med Ctr
  • Univ of Hawaii
  • Tulane Univ School of Medicine
  • SUNY / Health Sciences Ctr at Brooklyn
  • Beth Israel Med Ctr
  • St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
  • Mount Sinai Med Ctr
  • MetroHealth Med Ctr
  • Univ of Pennsylvania at Philadelphia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
March 1, 2011
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000950
Brief Title
Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis
Official Title
Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
May 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine if a relationship exists between the level of antituberculosis drugs (isoniazid, rifampin, ethambutol, and pyrazinamide) in the blood and the outcome of HIV-positive patients with tuberculosis. This study also evaluates how these drugs are absorbed and metabolized in the body.
Detailed Description
Patients receive up to 8 weeks of two or more anti-tuberculosis drugs, of which at least two are isoniazid, rifampin, pyrazinamide, or ethambutol. Blood specimens are collected at 2, 6, and 10 hours after administration of study medication, once between Days 10 and 14 of a phase of daily treatment and once while on an intermittent dose regimen (twice weekly or three times weekly).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Tuberculosis
Keywords
Tuberculosis, Isoniazid, Pyrazinamide, Pyridoxine, Rifampin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Ethambutol, Acquired Immunodeficiency Syndrome, Antitubercular Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ethambutol hydrochloride
Intervention Type
Drug
Intervention Name(s)
Isoniazid
Intervention Type
Drug
Intervention Name(s)
Pyrazinamide
Intervention Type
Drug
Intervention Name(s)
Pyridoxine hydrochloride
Intervention Type
Drug
Intervention Name(s)
Rifampin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive and have tuberculosis. Are 13 years of age or older. Have written, informed consent of parent or guardian if you are under 18 years of age. Agree to practice abstinence or use barrier methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have any other disorder or condition which might cause study treatment to be undesirable. Are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Chirgwin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Perlman
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Southern California / LA County USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
900331079
Country
United States
Facility Name
Harbor UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory Univ
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Queens Med Ctr
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Univ of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
112032098
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
MetroHealth Med Ctr
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
441091998
Country
United States
Facility Name
Univ of Pennsylvania at Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14765350
Citation
Perlman DC, Segal Y, Rosenkranz S, Rainey PM, Peloquin CA, Remmel RP, Chirgwin K, Salomon N, Hafner R; ACTG 309 Team. The clinical pharmacokinetics of pyrazinamide in HIV-infected persons with tuberculosis. Clin Infect Dis. 2004 Feb 15;38(4):556-64. doi: 10.1086/381096. Epub 2004 Jan 28.
Results Reference
background

Learn more about this trial

Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

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