|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Hoechst Marion Roussel |
|---|---|
| Collaborators: |
Lederle Laboratories National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000638 |
Purpose
To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis.
Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
| Condition | Intervention |
|---|---|
|
HIV Infections Tuberculosis |
Drug: Isoniazid Drug: Pyrazinamide Drug: Pyridoxine hydrochloride Drug: Rifampin |
| Study Type: | Interventional |
| Study Design: | Prevention, Parallel Assignment, Safety 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 from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
Patients are chosen by a random selection process to either the INH or the rifampin / pyrazinamide arm of the dose. Patients on the INH arm receive INH plus vitamin B6 (pyridoxine hydrochloride ) daily for 12 months. Patients on the other arm receive rifampin plus pyrazinamide for 60 days. Dosage of rifampin and pyrazinamide depends on weight of patient.
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:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Patients may not have the following prior conditions:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| Stanford Univ Med Ctr | |
| Stanford, California, United States, 943055107 | |
| Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | |
| San Jose, California, United States, 951282699 | |
| Children's Hosp of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| San Mateo AIDS Program / Stanford Univ | |
| Stanford, California, United States, 943055107 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Highland Gen Hosp / San Francisco Gen Hosp | |
| Oakland, California, United States, 946021018 | |
| Olive View Med Ctr | |
| Sylmar, California, United States, 91342 | |
| United States, Connecticut | |
| Yale Univ / New Haven | |
| New Haven, Connecticut, United States, 065102483 | |
| United States, District of Columbia | |
| Howard Univ | |
| Washington, District of Columbia, United States, 20059 | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Whitman - Walker Clinic / Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 200072197 | |
| HIV Ctr - District of Columbia Gen Hosp | |
| Washington, District of Columbia, United States, 200072197 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Hawaii | |
| Queens Med Ctr | |
| Honolulu, Hawaii, United States, 96816 | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Children's Mem Hosp Family Cln / Northwestern Univ Med Schl | |
| Chicago, Illinois, United States, 60611 | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| Louis A Weiss Memorial Hosp | |
| Chicago, Illinois, United States, 60640 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Maryland | |
| Johns Hopkins Hosp | |
| Baltimore, Maryland, United States, 21287 | |
| State of MD Div of Corrections / Johns Hopkins Univ Hosp | |
| Baltimore, Maryland, United States, 212052196 | |
| United States, Massachusetts | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| United States, Missouri | |
| St Louis Regional Hosp / St Louis Regional Med Ctr | |
| St Louis, Missouri, United States, 63112 | |
| United States, Nebraska | |
| Univ of Nebraska Med Ctr | |
| Omaha, Nebraska, United States, 681985130 | |
| United States, New Jersey | |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
| Newark, New Jersey, United States, 071032714 | |
| Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl | |
| Newark, New Jersey, United States, 071072198 | |
| United States, New York | |
| Montefiore Drug Treatment Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Montefiore Family Health Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| SUNY - Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| Nassau County Med Ctr | |
| East Meadow, New York, United States, 11554 | |
| SUNY / State Univ of New York | |
| Syracuse, New York, United States, 13210 | |
| Samaritan Village Inc / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Jack Weiler Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10465 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |
| Elmhurst, New York, United States, 11373 | |
| Mid - Hudson Care Ctr | |
| Albany, New York, United States, 122083479 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 112032098 | |
| Saint Clare's Hosp and Health Ctr | |
| New York, New York, United States, 10019 | |
| North Shore Univ Hosp | |
| Manhasset, New York, United States, 11030 | |
| North Central Bronx Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Comprehensive Health Care Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Columbia Presbyterian Med Ctr | |
| New York, New York, United States, 100323784 | |
| Adirondack Med Ctr at Saranac Lake | |
| Albany, New York, United States, 122083479 | |
| Montefiore Med Ctr Adolescent AIDS Program | |
| Bronx, New York, United States, 10467 | |
| Albany Med College / Division of HIV Medicine A158 | |
| Albany, New York, United States, 122083479 | |
| Interfaith Med Ctr | |
| Brooklyn, New York, United States, 112032098 | |
| United States, North Carolina | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Moses H Cone Memorial Hosp | |
| Greensboro, North Carolina, United States, 27401 | |
| Wake County Dept of Health | |
| Raleigh, North Carolina, United States, 27610 | |
| United States, Ohio | |
| Univ of Kentucky Lexington | |
| Cincinnati, Ohio, United States, 45267 | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| MetroHealth Med Ctr | |
| Cleveland, Ohio, United States, 441091998 | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Univ of Pennsylvania at Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Thomas Jefferson Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191075098 | |
| Girard Med Ctr | |
| Philadelphia, Pennsylvania, United States, 191046073 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Med Univ of South Carolina / UNC | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Meharry Med College | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77266 | |
| Puerto Rico | |
| Univ of Puerto Rico | |
| San Juan, Puerto Rico, 009365067 | |
| Study Chair: | Chaisson R |
More Information
| Study ID Numbers: | ACTG 177, CPCRA 004, TB/PPD+ |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000638 History of Changes |
| Health Authority: | Unspecified |
|
Tuberculosis Isoniazid Mycobacterium tuberculosis 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 |