Search / Trial NCT00000959

Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous Infection

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

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Trial Information

Current as of December 07, 2023

Completed

Keywords

Tuberculosis Isoniazid Pyridoxine Aids Related Opportunistic Infections Drug Evaluation Acquired Immunodeficiency Syndrome Antitubercular Agents

Description

A substantial number of HIV-infected persons are anergic, and thus do not respond to the only currently available diagnostic tool for tuberculosis infection (that is, the PPD (purified protein derivative) skin test). Many of these anergic persons are, however, infected with Mycobacterium tuberculosis and eventually develop reactivation tuberculosis, causing both individual illness and spread of infection to others in the community. This study examines the possibility of using INH prophylaxis (that is, for prevention) in anergic HIV-infected patients at high risk for tuberculosis as a means ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Antiretroviral therapy.
  • Pneumocystis carinii pneumonia prophylaxis.
  • Treatment for acute opportunistic infections/malignancies.
  • Patients must have:
  • Reasonably good health.
  • Life expectancy of at least six months.
  • Willing and able, in the clinician's opinion, to comply with the treatment and clinical management issues as outlined in the protocol.
  • HIV infection.
  • Signed informed consent.
  • Allowed:
  • Participation in other clinical trials as long as there is no potential activity of other study drugs against M. tuberculosis, additive toxicities between study agents, or known possible drug interactions between study drugs.
  • Must be in a high-risk group for Mycobacterium tuberculosis infection, including:
  • foreign-born from countries with a high prevalence of M. tuberculosis infection; from medically underserved low-income populations (high-risk racial or ethnic minority populations such as African Americans, Hispanic / Latinos, Native Americans, and/or the homeless, unemployed, inner city residents); alcohol or injectable drug users; or residents or former residents of high-risk, long-term care or residential facilities (correctional or mental institutions, nursing homes).
  • Prior Medication:
  • Allowed:
  • Previous treatment with quinolones/fluoroquinolones, aminoglycosides, or other agents with known or potential activity against M. tuberculosis.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Current active clinical tuberculosis, confirmed or suspected, or household contact with someone with active clinical tuberculosis.
  • History of sensitivity/intolerance to the study medication.
  • Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
  • Evidence of acute hepatitis.
  • Concurrent Medication:
  • Excluded:
  • -
  • Quinolones, fluoroquinolones, or aminoglycosides with antituberculous activity (may be used for up to 14 days for treatment of intercurrent infection). Other agents with known or potential antituberculosis activity should be avoided, including the following:
  • Aminosalicylic acid salts, capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, pyrazinamide, rifabutin, rifampin, streptomycin, or thiacetazone.
  • Prior Medication:
  • Excluded:
  • Treatment for more than 1 month (continuous or cumulative) with drugs that have known or potential antituberculous activity, other than quinolones, fluoroquinolones, and some aminoglycosides.
  • Patients may not have:
  • Current active clinical tuberculosis, confirmed or suspected, or household contact with someone with known active clinical tuberculosis.
  • Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
  • Unable or unwilling to have current therapy and/or concomitant medications changed to avoid serious interaction with study medication.
  • Documented history of a positive PPD skin test.
  • Participation in other clinical trials in which there is potential activity of other study drugs against M. tuberculosis, additive toxicities between study agents, or known possible drug interactions between study drugs.
  • Alcohol or injectable drug users.

Attachments

readout_NCT00000959_2023-12-07.pdf

4.5 MB

NCT00000959_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

Denver, Colorado, United States

New Haven, Connecticut, United States

Wilmington, Delaware, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Newark, New Jersey, United States

Bronx, New York, United States

Brooklyn, New York, United States

New York, New York, United States

New York, New York, United States

San Francisco, California, United States

Los Angeles, California, 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

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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