Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000950
First received: November 2, 1999
Last updated: March 1, 2011
Last verified: March 2011

November 2, 1999
March 1, 2011
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May 2002   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00000950 on ClinicalTrials.gov Archive Site
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Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis
Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis

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.

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).

Interventional
Not Provided
Primary Purpose: Treatment
  • HIV Infections
  • Tuberculosis
  • Drug: Ethambutol hydrochloride
  • Drug: Isoniazid
  • Drug: Pyrazinamide
  • Drug: Pyridoxine hydrochloride
  • Drug: Rifampin
Not Provided
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. Epub 2004 Jan 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Not Provided
May 2002   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000950
ACTG 309
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National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Keith Chirgwin
Study Chair: David Perlman
National Institute of Allergy and Infectious Diseases (NIAID)
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP