Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection

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.