Metabolism of Antituberculosis Drugs in HIV-Infected Persons With Tuberculosis
Pharmacokinetics of Antituberculosis Agents in HIV-Infected Persons With Tuberculosis
1 other identifier
interventional
50
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2002
CompletedMarch 2, 2011
March 1, 2011
November 2, 1999
March 1, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
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
Related Publications (1)
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.
PMID: 14765350BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Keith Chirgwin
- STUDY CHAIR
David Perlman
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Primary Completion
May 1, 2002
Last Updated
March 2, 2011
Record last verified: 2011-03