The Treatment of Tuberculosis in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

PER 5/30/95 AMENDMENT: In HIV-negative patients, intermittent anti-TB therapy has been shown to be as effective as daily therapy, but the optimal duration of therapy in HIV-infected patients has not been established.

ORIGINAL: In some areas of the country, resistance to one or more of the drugs commonly used to treat TB has emerged. Thus, the need to test regimens containing a new drug exists. Furthermore, the optimal duration of anti-TB therapy for HIV-infected patients with TB needs to be determined.

PER 5/30/95 AMENDMENT: Patients who have received an acceptable induction regimen prior...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • INDUCTION PHASE (ELIMINATED PER 5/30/95 AMENDMENT).
• • HIV infection.
• • Diagnosis of pulmonary TB.
• NOTE:
• • Patients from "susceptible" areas may be 13 years of age or older. Patients from "resistant" areas must be 18 years of age or older.
• • CONTINUATION PHASE.
• • Successful completion of induction phase and confirmation of TB by culture and susceptibility results.
• • Susceptibility to and tolerance of isoniazid and rifampin and no resistance to pyrazinamide.
• • HIV infection.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Multi-drug resistance to at least isoniazid and rifampin or known to have had close contact with a person with known multi-drug resistant TB.
• • Known treatment-limiting reaction to any of the study drugs.
• • Other disorders or conditions for which the study drugs are contraindicated.
• Concurrent Medication:
• Excluded:
• • Other medications with anti-TB activity.