The Treatment of Tuberculosis in HIV-Infected Patients

• Status: Completed
• Trial end date: 1997-07-01
• Target enrollment: 0
• Participant gender: All

Summary

PER 5/30/95 AMENDMENT: To compare the combined rate of failure during therapy and relapse after therapy between two durations of intermittent therapy (6 versus 9 months) for the treatment of pulmonary tuberculosis (TB) in HIV-infected patients. To compare toxicity, survival, and development of resistance in these two regimens.

ORIGINAL: To compare the efficacy and safety of induction and continuation therapies for the treatment of pulmonary TB in HIV-infected patients who are either from areas with known high rates of resistance to one or more anti-TB drugs or from areas where TB is expected to be susceptible to commonly used anti-TB drugs.

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ethambutol; Isoniazid; Levofloxacin; Ofloxacin; Pyrazinamide; Pyridoxal; Pyridoxine; Rifampin; Vitamin B 6

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.