Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous Infection
NCT ID: NCT00000959
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
1996-06-30
Brief Summary
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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 of decreasing the sharp rise in the incidence of tuberculosis due to HIV infection. INH is inexpensive and relatively safe, and thus may demonstrate an acceptable risk/benefit ratio as a medication that can be given over a limited period of time to a population suspected of having, but not proved to have, M. tuberculosis infection. If this study shows INH to be safe and effective in this setting, it could have a major effect on public health in this country.
Detailed Description
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Patients are placed by a random selection process in either the INH or placebo group. One group receives INH plus pyridoxine hydrochloride ( vitamin B6 ) daily for six months. Patients in the other group receive placebo plus vitamin B6 daily for six months.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Isoniazid
Pyridoxine hydrochloride
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Gordin F
Role: STUDY_CHAIR
Locations
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UCLA Med Ctr
Los Angeles, California, United States
Community Consortium of San Francisco
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Hill Health Corp
New Haven, Connecticut, United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Addiction Research and Treatment Corp
Brooklyn, New York, United States
Clinical Directors Network of Region II
New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Countries
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References
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Gordin FM, Matts JP, Miller C, Brown LS, Hafner R, John SL, Klein M, Vaughn A, Besch CL, Perez G, Szabo S, El-Sadr W. A controlled trial of isoniazid in persons with anergy and human immunodeficiency virus infection who are at high risk for tuberculosis. Terry Beirn Community Programs for Clinical Research on AIDS. N Engl J Med. 1997 Jul 31;337(5):315-20. doi: 10.1056/NEJM199707313370505.
Other Identifiers
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11557
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 005
Identifier Type: -
Identifier Source: org_study_id