Status:
COMPLETED
Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Hoechst Marion Roussel
Lederle Laboratories
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
13+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 effec...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1999
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00000638
End Date
September 1 1999
Last Update
November 2 2021
Active Locations (76)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Children's Hosp of Los Angeles
Los Angeles, California, United States, 90027
3
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
4
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States, 946021018