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CompletedNCT00000950Updated Mar 2, 2011

Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis

An interventional study of Ethambutol hydrochloride and Isoniazid in HIV Infections and Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 13 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2011-03-02.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Ages
13 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • HIV Infections
  • Tuberculosis

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Keywords

  • Tuberculosis
  • Isoniazid
  • Pyrazinamide
  • Pyridoxine
  • Rifampin
  • AIDS-Related Opportunistic Infections
  • Drug Therapy, Combination
  • Ethambutol
  • Acquired Immunodeficiency Syndrome
  • Antitubercular Agents
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In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 50 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Enrollment
50 participants

Interventions

  • DrugEthambutol hydrochloride
  • DrugIsoniazid
  • DrugPyrazinamide
  • DrugPyridoxine hydrochloride
  • DrugRifampin
06

Study locations

13 sites
  • Univ of Southern California / LA County USC Med Ctr
    Los Angeles, California 900331079, United States
  • Harbor UCLA Med Ctr
    Torrance, California 90502, United States
  • University of Miami (Pediatric)
    Miami, Florida 33136, United States
  • Emory Univ
    Atlanta, Georgia 30308, United States
  • Queens Med Ctr
    Honolulu, Hawaii 96816, United States
  • Univ of Hawaii
    Honolulu, Hawaii 96816, United States
  • Tulane Univ School of Medicine
    New Orleans, Louisiana 70112, United States
  • SUNY / Health Sciences Ctr at Brooklyn
    Brooklyn, New York 112032098, United States
  • Beth Israel Med Ctr
    New York, New York 10003, United States
  • St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
    New York, New York 10021, United States
  • Mount Sinai Med Ctr
    New York, New York 10029, United States
  • MetroHealth Med Ctr
    Cleveland, Ohio 441091998, United States
  • Univ of Pennsylvania at Philadelphia
    Philadelphia, Pennsylvania 19104, United States
07

References and documents

Publications

  • 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. PubMed 14765350 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000950
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Aug 31, 2001
Primary completion
May 2002
Last update
Mar 2, 2011

Study contacts

Keith Chirgwin
study chair
David Perlman
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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