Search / Trial NCT00000796

A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) 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 June 14, 2024

Completed

Keywords

Isoniazid Tuberculosis, Pulmonary Pyrazinamide Pyridoxine Ofloxacin Rifampin Aids Related Opportunistic Infections Drug Therapy, Combination Ethambutol Clofazimine Acquired Immunodeficiency Syndrome Amikacin Drug Resistance, Microbial Cycloserine Capreomycin Sulfate Ethionamide Aminosalicylic Acids Streptomycin P Aminosalicylic Acid

Description

Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion. Patients are asked a series of questions to determine epidemiologic fact...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Working diagnosis of HIV infection.
  • Working diagnosis of pulmonary TB.
  • Per 08/02/94 amendment, patients with confirmed MDRTB or known susceptibilities for the current episode at baseline are not eligible for the epidemiologic study only.
  • FOR TREATMENT PILOT:
  • Positive sputum AFB smear (or a positive sputum culture for TB within 6 months prior to study entry).
  • Assessment of suspect primary, suspect acquired, AND/OR confirmed MDRTB.
  • Life expectancy of at least 2 weeks.
  • Age >= 18 years for suspect MDRTB. Age >= 13 years for confirmed MDRTB.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Known hypersensitivity or resistance to quinolones.
  • Other disorders or conditions for which the study drugs are contraindicated.
  • Prior Medication:
  • Excluded:
  • More than 6 weeks total therapy within 3 months prior to study entry using three or more drugs effective against the isolates. (Per 08/02/94 amendment, patients from protocol ACTG 222/CPCRA 019 who have MDRTB are eligible for rollover to this study regardless of treatment duration on ACTG 222/CPCRA 019.)

Attachments

readout_NCT00000796_2024-06-14.pdf

4.5 MB

NCT00000796_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

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Detroit, Michigan, United States

Bronx, New York, United States

New York, New York, United States

New York, New York, United States

Chicago, Illinois, United States

New York, New York, United States

New York, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Bronx, New York, United States

Brooklyn, New York, United States

Brooklyn, New York, United States

New York, 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

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

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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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