Search / Trial NCT00001033

The Treatment of Tuberculosis in HIV-Infected Patients

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

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Isoniazid Tuberculosis, Pulmonary Pyrazinamide Pyridoxine Ofloxacin Rifampin Aids Related Opportunistic Infections Ethambutol Acquired Immunodeficiency Syndrome

Description

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.

Attachments

readout_NCT00001033_2024-03-02.pdf

4.5 MB

NCT00001033_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Buffalo, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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