Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 09, 2025
Completed
Keywords
ClinConnect Summary
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 sh...
Gender
ALL
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Los Angeles, California, United States
Indianapolis, Indiana, United States
Springfield, Massachusetts, United States
Saint Louis, Missouri, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Columbus, Ohio, United States
West Columbia, South Carolina, United States
San Francisco, California, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Washington, District Of Columbia, United States
Newark, New Jersey, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Los Angeles, California, United States
Oakland, California, United States
San Francisco, California, United States
San Jose, California, United States
Stanford, California, United States
Stanford, California, United States
Sylmar, California, United States
Torrance, California, United States
New Haven, Connecticut, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Omaha, Nebraska, United States
Newark, New Jersey, United States
Albany, New York, United States
Albany, New York, United States
Albany, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Bronx, New York, United States
Brooklyn, New York, United States
Brooklyn, New York, United States
Buffalo, New York, United States
East Meadow, New York, United States
Elmhurst, New York, United States
Manhasset, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Greensboro, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Galveston, Texas, United States
Houston, Texas, United States
San Juan, , Puerto Rico
Patients applied
Trial Officials
Chaisson R
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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