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| Sponsor: | Centers for Disease Control and Prevention |
|---|---|
| Collaborator: |
Department of Veterans Affairs |
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00023413 |
Purpose
The aim of this trial is to study the efavirenz-rifabutin interaction. Thus, this trial will enroll patients with HIV and tuberculosis co-infections who are receiving a rifabutin-based regimen and who plan to begin an antiretroviral regimen containing efavirenz dosed at 600 mg daily. Enrollment in TB Trials Consortium Study 23 is not a requirement for participation in this study.
Primary Objective:
To compare the pharmacokinetics of rifabutin at 600 mg twice a week in combination with efavirenz 600 mg daily to the pharmacokinetics of rifabutin 300 mg twice a week without efavirenz.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: Rifabutin Drug: Efavirenz |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | TBTC Study 23C: Intensive Pharmacokinetic Study of Intermittent Rifabutin and Isoniazid With Daily Efavirenz in Combination With Two Nucleoside Analogs for Treatment of HIV and Tuberculosis Co-Infections |
| Estimated Enrollment: | 20 |
| Study Start Date: | November 1999 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Hide Study Locations| 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 | |
| Hines VA Medical Center | |
| Hines, Illinois, United States, 60141 | |
| Chicago VA Medical Center (Lakeside) | |
| Chicago, Illinois, United States, 60611 | |
| 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 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 34222 | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| 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 | |
| Principal Investigator: | Marc Weiner, MD | San Antonio VAMC, San Antonio TX |
More Information
| Study ID Numbers: | CDC-NCHSTP-2588, 23C |
| Study First Received: | September 6, 2001 |
| Last Updated: | September 1, 2005 |
| ClinicalTrials.gov Identifier: | NCT00023413 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
tuberculosis TB |
|
Bacterial Infections Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Rifabutin Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Bacterial Agents Gram-Positive Bacterial Infections Anti-Retroviral Agents Therapeutic Uses Tuberculosis Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors Efavirenz RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Actinomycetales Infections Pharmacologic Actions Antibiotics, Antitubercular Virus Diseases HIV Infections Sexually Transmitted Diseases |
