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

Completed · Not applicable

Conditions studied: HIV Infections, Tuberculosis

In brief

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.

Key facts

Study ID

NCT00000959

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

600

Expected to finish

1996-06-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.