Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous Infection

Inclusion Criteria

Concurrent Medication:

Allowed:

• Antiretroviral therapy.
• Pneumocystis carinii pneumonia prophylaxis.
• Treatment for acute opportunistic infections/malignancies.

Patients must have:

• Reasonably good health.
• Life expectancy of at least six months.
• Willing and able, in the clinician's opinion, to comply with the treatment and clinical management issues as outlined in the protocol.
• HIV infection.
• Signed informed consent.

Allowed:

• Participation in other clinical trials as long as there is no potential activity of other study drugs against M. tuberculosis, additive toxicities between study agents, or known possible drug interactions between study drugs.
• Must be in a high-risk group for Mycobacterium tuberculosis infection, including:
• foreign-born from countries with a high prevalence of M. tuberculosis infection; from medically underserved low-income populations (high-risk racial or ethnic minority populations such as African Americans, Hispanic / Latinos, Native Americans, and/or the homeless, unemployed, inner city residents); alcohol or injectable drug users; or residents or former residents of high-risk, long-term care or residential facilities (correctional or mental institutions, nursing homes).

Prior Medication:

Allowed:

• Previous 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 clinical tuberculosis, confirmed or suspected, or household contact with someone with active clinical tuberculosis.
• History of sensitivity/intolerance to the study medication.
• Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
• Evidence of acute hepatitis.

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 antituberculosis activity should be avoided, including the following:

• Aminosalicylic acid salts, capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, pyrazinamide, rifabutin, rifampin, streptomycin, or thiacetazone.

Prior Medication:

Excluded:

• Treatment for more than 1 month (continuous or cumulative) with drugs that have known or potential antituberculous activity, other than quinolones, fluoroquinolones, and some aminoglycosides.

Patients may not have:

• Current active clinical tuberculosis, confirmed or suspected, or household contact with someone with known active clinical tuberculosis.
• Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
• Unable or unwilling to have current therapy and/or concomitant medications changed to avoid serious interaction with study medication.
• Documented history of a positive PPD skin test.
• Participation in other clinical trials in which there is potential activity of other study drugs against M. tuberculosis, additive toxicities between study agents, or known possible drug interactions between study drugs.

Alcohol or injectable drug users.