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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Isoniazid
Pyridoxine hydrochloride
Ethambutol
Pyrazinamide
Ethambutol hydrochloride
Rifampin
U.S. FDA Resources
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) |
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
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 March 03, 2013
