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
  Purpose

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 Intervention
HIV Infections
Tuberculosis
Drug: Ethambutol hydrochloride
Drug: Isoniazid
Drug: Pyrazinamide
Drug: Pyridoxine hydrochloride
Drug: Rifampin

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 50
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000950

Locations
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
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
Beth Israel Med Ctr
New York, New York, United States, 10003
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
Investigators
Study Chair: Keith Chirgwin
Study Chair: David Perlman
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00000950     History of Changes
Other Study ID Numbers: ACTG 309
Study First Received: November 2, 1999
Last Updated: March 1, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Tuberculosis
Isoniazid
Pyrazinamide
Pyridoxine
Rifampin
AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Ethambutol
Acquired Immunodeficiency Syndrome
Antitubercular Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antitubercular Agents
Ethambutol
Isoniazid
Pyrazinamide
Rifampin
Pyridoxine
Vitamin B 6
Pyridoxal
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents

ClinicalTrials.gov processed this record on August 19, 2014