The Treatment of Tuberculosis in HIV-Infected Patients

Completed · Phase 3

Conditions studied: HIV Infections, Tuberculosis

In brief

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.

Key facts

Study ID

NCT00001033

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

650

Expected to finish

1997-07-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC CRS — Los Angeles, California, United States
• Howard University Hosp., Div. of Infectious Diseases, ACTU — Washington D.C., District of Columbia, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• SUNY - Buffalo, Erie County Medical Ctr — Buffalo, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Cornell University A2201 — New York, New York, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
• Univ. of Cincinnati CRS — Cincinnati, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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