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Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000950
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 2, 2011
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Tuberculosis Drug: Ethambutol hydrochloride Drug: Isoniazid Drug: Pyrazinamide Drug: Pyridoxine hydrochloride Drug: Rifampin Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis
Actual Primary Completion Date : May 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000950

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United States, California
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
United States, Florida
University of Miami (Pediatric)
Miami, Florida, United States, 33136
United States, Georgia
Emory Univ
Atlanta, Georgia, United States, 30308
United States, Hawaii
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
United States, Louisiana
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, New York
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 112032098
Beth Israel Med Ctr
New York, New York, United States, 10003
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, United States, 10021
Mount Sinai Med Ctr
New York, New York, United States, 10029
United States, Ohio
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Keith Chirgwin
Study Chair: David Perlman
Additional Information:
Layout table for additonal information Identifier: NCT00000950    
Other Study ID Numbers: ACTG 309
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: March 2011
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Antitubercular Agents
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vitamin B 6
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Vitamin B Complex