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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Department of Veterans Affairs |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00023348 |
Primary Objectives:
1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.
Secondary Objectives:
Condition | Intervention | Phase |
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HIV Infections Tuberculosis |
Drug: Isoniazid Drug: Rifabutin |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics Study |
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 |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
1. Severe anemia (Hct <25%)
Principal Investigator: | Marc Weiner, MD | Audie L. Murphy VA Medical Center, San Antonio TX |
Study ID Numbers: | CDC-NCHSTP-2173, 23A |
Study First Received: | September 6, 2001 |
Last Updated: | September 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00023348 History of Changes |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Tuberculosis TB |
Antimetabolites Bacterial Infections Sexually Transmitted Diseases, Viral Rifabutin Antilipemic Agents Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Anti-Bacterial Agents |
Gram-Positive Bacterial Infections HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Tuberculosis Antitubercular Agents Retroviridae Infections Isoniazid |
Bacterial Infections Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Rifabutin Molecular Mechanisms of Pharmacological Action Infection Anti-Bacterial Agents Gram-Positive Bacterial Infections Therapeutic Uses Tuberculosis Retroviridae Infections Isoniazid RNA Virus Infections |
Immune System Diseases Antilipemic Agents Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Actinomycetales Infections Pharmacologic Actions Antibiotics, Antitubercular Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections Antitubercular Agents Fatty Acid Synthesis Inhibitors |