TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023348
First received: September 6, 2001
Last updated: September 9, 2005
Last verified: September 2005
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Primary Objectives:
1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.
Secondary Objectives:
- To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin.
- To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
- To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
- To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: Isoniazid Drug: Rifabutin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in USPHS Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.
Secondary Outcome Measures:
- 1) To determine risk factors for abnormal pharmacokinetics of isoniazid and rifabutin
- 2) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
- 3) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
- 4) To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
| Estimated Enrollment: | 150 |
| Study Start Date: | July 1999 |
| Estimated Study Completion Date: | November 2002 |
This study will seek to enroll every eligible patient enrolled in TBTC Study 23. Consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion:
- Patient enrolled in TBTC Study 23
- Informed consent
Exclusion:
1. Severe anemia (Hct <25%)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023348
Hide Study Locations
Hide Study LocationsLocations
| United States, Arkansas | |
| Central Arkansas Veterans Health System | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| LA County/USC Medical Center | |
| Los Angeles, California, United States, 90033 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94110 | |
| United States, Colorado | |
| Denver Department of Public Health and Hospitals | |
| Denver, Colorado, United States, 80204 | |
| United States, District of Columbia | |
| Washington, D.C. VAMC | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Illinois | |
| Chicago VA Medical Center (Lakeside) | |
| Chicago, Illinois, United States, 60611 | |
| Hines VA Medical Center | |
| Hines, Illinois, United States, 60141 | |
| United States, Maryland | |
| Johns Hopkins University School of Medicine | |
| Baltimore, Maryland, United States, 21287-0003 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, New Jersey | |
| New Jersey Medical School | |
| Newark, New Jersey, United States, 07107-3001 | |
| United States, New York | |
| New York University School of Medicine | |
| New York, New York, United States, 10016 | |
| Columbia University/Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| Harlem Hospital Center | |
| New York, New York, United States, 10037 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 34222 | |
| United States, Tennessee | |
| Nashville VA Medical Center | |
| Nashville, Tennessee, United States, 37212-2637 | |
| United States, Texas | |
| University of North Texas Health Science Center | |
| Fort Worth, Texas, United States, 76107-2699 | |
| Thomas Street Clinic | |
| Houston, Texas, United States, 77009 | |
| Audi L. Murphy VA Hospital | |
| San Antonio, Texas, United States, 78284 | |
| United States, Washington | |
| Seattle King County Health Department | |
| Seattle, Washington, United States, 98104 | |
| Canada, British Columbia | |
| University of British Columbia | |
| Vancouver, British Columbia, Canada, Canada V5Z 4R4 | |
| Canada, Manitoba | |
| University of Manitoba | |
| Winnipeg, Manitoba, Canada, CANADA R3A 1R8 | |
| Canada, Quebec | |
| Montreal Chest Institute McGill University | |
| Montreal, Quebec, Canada, H2X 2P4Pq Canada | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Marc Weiner, MD | Audie L. Murphy VA Medical Center, San Antonio TX |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00023348 History of Changes |
| Other Study ID Numbers: | CDC-NCHSTP-2173, 23A |
| Study First Received: | September 6, 2001 |
| Last Updated: | September 9, 2005 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Centers for Disease Control and Prevention:
|
Tuberculosis TB |
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 Isoniazid Rifabutin Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents Antibiotics, Antitubercular |
ClinicalTrials.gov processed this record on June 17, 2013