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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000959 |
To evaluate the safety and effectiveness of a 6-month course of isoniazid ( INH ) in the prevention of clinical tuberculosis in anergic (having diminished or absent reactions to specific antigens) HIV-infected persons who are at high risk for tuberculous infection.
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.
Condition | Intervention |
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HIV Infections Tuberculosis |
Drug: Isoniazid Drug: Pyridoxine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment |
Official Title: | Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Suspected Latent Tuberculous Infection |
Estimated Enrollment: | 600 |
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.
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Allowed:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
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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:
Prior Medication:
Excluded:
Patients may not have:
Alcohol or injectable drug users.
United States, California | |
UCLA Med Ctr | |
Los Angeles, California, United States, 90095 | |
Community Consortium of San Francisco | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Denver CPCRA / Denver Public Hlth | |
Denver, Colorado, United States, 802044507 | |
United States, Connecticut | |
Hill Health Corp | |
New Haven, Connecticut, United States, 06519 | |
United States, Delaware | |
Wilmington Hosp / Med Ctr of Delaware | |
Wilmington, Delaware, United States, 19899 | |
United States, District of Columbia | |
Veterans Administration Med Ctr / Regional AIDS Program | |
Washington, District of Columbia, United States, 20422 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Louisiana | |
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
New Orleans, Louisiana, United States, 70112 | |
United States, Michigan | |
Comprehensive AIDS Alliance of Detroit | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
North Jersey Community Research Initiative | |
Newark, New Jersey, United States, 071032842 | |
United States, New York | |
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
Addiction Research and Treatment Corp | |
Brooklyn, New York, United States, 11201 | |
Clinical Directors Network of Region II | |
New York, New York, United States, 10011 | |
Bronx Lebanon Hosp Ctr | |
Bronx, New York, United States, 10456 |
Study Chair: | Gordin F |
Study ID Numbers: | CPCRA 005 |
Study First Received: | November 2, 1999 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00000959 |
Health Authority: | United States: Federal Government |
Tuberculosis Isoniazid Pyridoxine AIDS-Related Opportunistic Infections |
Drug Evaluation Acquired Immunodeficiency Syndrome Antitubercular Agents |
Bacterial Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Vitamin B 6 Immunologic Deficiency Syndromes Virus Diseases Gram-Positive Bacterial Infections |
HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Mycobacterium Infections Pyridoxine Tuberculosis Retroviridae Infections Isoniazid |
Antimetabolites Anti-Infective Agents Communicable Diseases RNA Virus Infections Vitamin B Complex Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Growth Substances Antilipemic Agents Physiological Effects of Drugs |
Infection Actinomycetales Infections Pharmacologic Actions Anti-Bacterial Agents Vitamins Therapeutic Uses Lentivirus Infections Micronutrients Antitubercular Agents Fatty Acid Synthesis Inhibitors |