Prophylaxis 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 14, 2025
Completed
Keywords
ClinConnect Summary
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, pa...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • Antiretroviral treatment.
- • Pneumocystis carinii pneumonia prophylaxis.
- • Treatment for acute opportunistic infection/malignancy.
- • Aminoglycosides, quinolones or fluoroquinolones such as ciprofloxacin or ofloxacin for \< 14 days for treatment of intercurrent infection.
- Patients must have:
- • HIV infection.
- • Signed informed consent.
- • Reasonably good health at time of study entry.
- • Perceived life expectancy of at least six months.
- * 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.
- Prior Medication:
- Allowed:
- • Treatment with quinolones, fluoroquinolones, aminoglycosides, or other agents with known or potential activity against M. tuberculosis.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- • Current active tuberculosis (confirmed or suspected).
- • Sensitivity or intolerance to study medication.
- • Acute hepatitis.
- • Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
- • Inability to have concomitant medications changed to avoid serious interaction with study drug.
- 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:
- • Aminosalicylic acid salts, capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, pyrazinamide, rifabutin, rifampin, streptomycin, and thiacetazone.
- Prior Medication:
- Excluded:
- • History of treatment for \> 2 months with agents that have known or potential antituberculous activity other than those specifically allowed.
- Agents with potential or known antituberculous activity include the following:
- • Aminoglycosides such as amikacin, aminosalicylic acid salts, capreomycin, ciprofloxacin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, ofloxacin, pyrazinamide, quinolones or fluoroquinolones, rifabutin, rifampin, streptomycin, and thiacetazone.
- Patients may not have:
- • Current active tuberculosis.
- • Acute hepatitis.
- • Peripheral neuropathy of grade 3 or grade 4.
- • Willing and able, in the clinician's opinion, to comply with the treatment and clinical management issues.
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
New York, New York, United States
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Wilmington, Delaware, United States
Washington, District Of Columbia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Camden, New Jersey, United States
Newark, New Jersey, United States
Newark, New Jersey, United States
Newark, New Jersey, United States
Bronx, New York, United States
Brooklyn, New York, United States
New York, New York, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
Richmond, Virginia, United States
Patients applied
Trial Officials
Gordin F
Study Chair
Brown LS
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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