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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000636 |
Purpose
To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb).
Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
| Condition | Intervention |
|---|---|
|
HIV Infections Tuberculosis |
Drug: Isoniazid Drug: Pyrazinamide Drug: Pyridoxine hydrochloride Drug: Rifampin |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Efficacy Study |
| Official Title: | Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection |
| Estimated Enrollment: | 2000 |
Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
After baseline screening, patients are randomized to one of two treatment arms and are evaluated by means of clinic visits monthly for the first three months, then every three months for the first year (there are additional clinic visits for INH patients). Patients are then evaluated every six months. One group of patients takes INH plus vitamin B6 for 12 months. The other group of patients takes 1 of 2 doses of rifampin (depending on patient's weight) plus pyrazinamide in 3-4 divided doses for 60 days.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
-
Quinolones, fluoroquinolones, or aminoglycosides with antituberculous activity (may be used for up to 14 days for treatment of intercurrent infection).Other agents with known or potential antituberculous activity should be avoided, including the following:
Prior Medication:
Excluded:
Agents with potential or known antituberculous activity include the following:
Patients may not have:
Willing and able, in the clinician's opinion, to comply with the treatment and clinical management issues.
Contacts and Locations
Hide Study Locations| United States, California | |
| Community Consortium / UCSF | |
| San Francisco, California, United States, 94110 | |
| United States, Colorado | |
| Denver CPCRA / Denver Public Hlth | |
| Denver, Colorado, United States, 802044507 | |
| United States, Connecticut | |
| Hill Health Corp | |
| New Haven, Connecticut, United States, 06519 | |
| United States, Delaware | |
| Wilmington Hosp / Med Ctr of Delaware | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Veterans Administration Med Ctr / Regional AIDS Program | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| AIDS Research Alliance - Chicago | |
| Chicago, Illinois, United States, 60657 | |
| Chicago Dept of Health / Speciality STD Clinic | |
| Chicago, Illinois, United States, 60605 | |
| United States, Louisiana | |
| Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Johns Hopkins Univ / School of Hygiene & Public Health | |
| Baltimore, Maryland, United States, 212052179 | |
| Johns Hopkins Univ / Brazil | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Boston Dept of Health and Hosps | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| Comprehensive AIDS Alliance of Detroit | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Lattimore Comprehensive Pulmonary Disease Clinic | |
| Newark, New Jersey, United States, 07103 | |
| Saint Michael's Med Ctr | |
| Newark, New Jersey, United States, 07102 | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 071032842 | |
| Southern New Jersey AIDS Cln Trials / Dept of Med | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10456 | |
| Clinical Directors Network of Region II | |
| New York, New York, United States, 10011 | |
| Addiction Research and Treatment Corp | |
| Brooklyn, New York, United States, 11201 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10035 | |
| United States, Pennsylvania | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Virginia | |
| Richmond AIDS Consortium | |
| Richmond, Virginia, United States, 23298 | |
| Study Chair: | Gordin F | |
| Study Chair: | Brown LS |
More Information
| Study ID Numbers: | CPCRA 004, TB/PPD+, ACTG 177 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000636 History of Changes |
| Health Authority: | United States: Federal Government |
|
Tuberculosis Isoniazid Pyrazinamide Pyridoxine Rifampin |
AIDS-Related Opportunistic Infections Drug Therapy, Combination Acquired Immunodeficiency Syndrome Antitubercular Agents AIDS-Related Complex |
|
Antimetabolites Bacterial Infections Anti-Infective Agents Communicable Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Vitamin B 6 Anti-Bacterial Agents Rifampin Gram-Positive Bacterial Infections Pyridoxal Vitamins |
Therapeutic Uses Tuberculosis Micronutrients Retroviridae Infections Nucleic Acid Synthesis Inhibitors Isoniazid RNA Virus Infections Vitamin B Complex Immune System Diseases Growth Substances Antilipemic Agents Acquired Immunodeficiency Syndrome Enzyme Inhibitors Pyrazinamide Pharmacologic Actions |