Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
HIV Infections, Tuberculosis
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Tuberculosis, Isoniazid, Mycobacterium tuberculosis, Pyrazinamide, Pyridoxine, Rifampin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antitubercular Agents, AIDS-Related Complex
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral treatment. Pneumocystis carinii pneumonia prophylaxis. Treatment for acute opportunistic infection. Patients must have: HIV infection. Current or documented history of positive PPD skin test. Life expectancy of at least 6 months or, in the physician's opinion, patient has a reasonable chance of survival to end of study. Allowed: Participation in other clinical trials as long as there is no potential activity of other study drugs against Mycobacterium tuberculosis (MTb), additive toxicities between study agents, or known possible drug interactions between study drugs. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Current active clinical tuberculosis, confirmed or suspected. History of sensitivity / intolerance to any study medication. Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse. Unwilling or unable to have current therapy and/or concomitant medication changed to avoid serious interaction with study medication. Acute hepatitis. Unable to comply with the follow-up requirements of the protocol. Concurrent Medication: Excluded: Treatment with quinolones, fluoroquinolones, aminoglycosides, or other agents that have activity against Mycobacterium tuberculosis. Excluded as ongoing (i.e., continuous, chronic and/or recurring) treatment: Aminoglycosides such as amikacin, aminosalicylic acid salts (PAS), capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid (INH) if randomized to rifampin/pyrazinamide arm of study, kanamycin, pyrazinamide if randomized to INH arm of study, and quinolones and fluoroquinolones, i.e., rifabutin, rifampin (if randomized to INH arm of study), ciprofloxacin, levofloxacin, ofloxacin, streptomycin, and thiacetazone. Prior Medication: Excluded: More than 2 months of continuous treatment, after documentation of a positive PPD skin test, with agents that have known or potential antituberculous activity or any antimycobacterial medication for > 1 month. Patients may not have the following prior conditions: History of sensitivity / intolerance to any study medication. Unwilling or unable to comply with the follow-up requirements of the protocol.
Sites / Locations
- Univ of Alabama at Birmingham
- Children's Hosp of Los Angeles
- Univ of Southern California / LA County USC Med Ctr
- Highland Gen Hosp / San Francisco Gen Hosp
- San Francisco Gen Hosp
- Stanford at Kaiser / Kaiser Permanente Med Ctr
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
- San Mateo AIDS Program / Stanford Univ
- Stanford Univ Med Ctr
- Olive View Med Ctr
- Harbor UCLA Med Ctr
- Yale Univ / New Haven
- HIV Ctr - District of Columbia Gen Hosp
- Whitman - Walker Clinic / Georgetown Univ Med Ctr
- Georgetown Univ Med Ctr
- Howard Univ
- Univ of Miami School of Medicine
- Queens Med Ctr
- Univ of Hawaii
- Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
- Northwestern Univ Med School
- Rush Presbyterian - Saint Luke's Med Ctr
- Louis A Weiss Memorial Hosp
- Indiana Univ Hosp
- State of MD Div of Corrections / Johns Hopkins Univ Hosp
- Johns Hopkins Hosp
- Beth Israel Deaconess - West Campus
- Baystate Med Ctr of Springfield
- St Louis Regional Hosp / St Louis Regional Med Ctr
- Univ of Nebraska Med Ctr
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
- Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
- Adirondack Med Ctr at Saranac Lake
- Albany Med College / Division of HIV Medicine A158
- Mid - Hudson Care Ctr
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
- Comprehensive Health Care Ctr / Bronx Municipal Hosp
- Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
- Montefiore Family Health Ctr / Bronx Municipal Hosp
- Samaritan Village Inc / Bronx Municipal Hosp
- Jack Weiler Hosp / Bronx Municipal Hosp
- Montefiore Med Ctr / Bronx Municipal Hosp
- Montefiore Med Ctr Adolescent AIDS Program
- North Central Bronx Hosp / Bronx Municipal Hosp
- Interfaith Med Ctr
- SUNY / Health Sciences Ctr at Brooklyn
- SUNY / Erie County Med Ctr at Buffalo
- Nassau County Med Ctr
- City Hosp Ctr at Elmhurst / Mount Sinai Hosp
- North Shore Univ Hosp
- Beth Israel Med Ctr
- Bellevue Hosp / New York Univ Med Ctr
- Saint Clare's Hosp and Health Ctr
- Cornell Univ Med Ctr
- Saint Luke's - Roosevelt Hosp Ctr
- Mount Sinai Med Ctr
- Columbia Presbyterian Med Ctr
- SUNY - Stony Brook
- SUNY / State Univ of New York
- Univ of North Carolina
- Moses H Cone Memorial Hosp
- Wake County Dept of Health
- Univ of Cincinnati
- Univ of Kentucky Lexington
- Case Western Reserve Univ
- MetroHealth Med Ctr
- Ohio State Univ Hosp Clinic
- Girard Med Ctr
- Univ of Pennsylvania at Philadelphia
- Thomas Jefferson Univ Hosp
- Med Univ of South Carolina / UNC
- Julio Arroyo
- Meharry Med College
- Univ of Texas Galveston
- Houston Clinical Research Network
- Univ of Puerto Rico