Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection

Completed · Not applicable

Conditions studied: HIV Infections, Tuberculosis

In brief

To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.

Key facts

Study ID: NCT00000638
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 2000
Expected to finish: 1999-09-01
Last updated by the study team: 2021-11-02

Who can join

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

You may qualify if…

Concurrent Medication:
Allowed:
Antiretroviral treatment.
Pneumocystis carinii pneumonia prophylaxis.
Treatment for acute opportunistic infection.
Patients must have:
HIV infection.
Current or documented history of positive PPD skin test.
Life expectancy of at least 6 months or, in the physician's opinion, patient has a reasonable chance of survival to end of study.
Allowed:
Participation in other clinical trials as long as there is no potential activity of other study drugs against Mycobacterium tuberculosis (MTb), additive toxicities between study agents, or known possible drug interactions between study drugs.

You may not qualify if…

Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Current active clinical tuberculosis, confirmed or suspected.
History of sensitivity / intolerance to any study medication.
Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
Unwilling or unable to have current therapy and/or concomitant medication changed to avoid serious interaction with study medication.
Acute hepatitis.
Unable to comply with the follow-up requirements of the protocol.
Concurrent Medication:
Excluded:
Treatment with quinolones, fluoroquinolones, aminoglycosides, or other agents that have activity against Mycobacterium tuberculosis.
Excluded as ongoing (i.e., continuous, chronic and/or recurring) treatment:
Aminoglycosides such as amikacin, aminosalicylic acid salts (PAS), capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid (INH) if randomized to rifampin/pyrazinamide arm of study, kanamycin, pyrazinamide if randomized to INH arm of study, and quinolones and fluoroquinolones, i.e., rifabutin, rifampin (if randomized to INH arm of study), ciprofloxacin, levofloxacin, ofloxacin, streptomycin, and thiacetazone.
Prior Medication:
Excluded:
More than 2 months of continuous treatment, after documentation of a positive PPD skin test, with agents that have known or potential antituberculous activity or any antimycobacterial medication for > 1 month.
Patients may not have the following prior conditions:
History of sensitivity / intolerance to any study medication.
Unwilling or unable to comply with the follow-up requirements of the protocol.

Where it is running

Children's Hosp of Los Angeles — Los Angeles, California, United States
Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp — Oakland, California, United States
San Francisco Gen Hosp — San Francisco, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr — San Francisco, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium — San Jose, California, United States
San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
Stanford Univ Med Ctr — Stanford, California, United States
Olive View Med Ctr — Sylmar, California, United States
Harbor UCLA Med Ctr — Torrance, California, United States
Yale Univ / New Haven — New Haven, Connecticut, United States
HIV Ctr - District of Columbia Gen Hosp — Washington D.C., District of Columbia, United States
Whitman - Walker Clinic / Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
Howard Univ — Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine — Miami, Florida, United States
Queens Med Ctr — Honolulu, Hawaii, United States
Univ of Hawaii — Honolulu, Hawaii, United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl — Chicago, Illinois, United States
Northwestern Univ Med School — Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
Louis A Weiss Memorial Hosp — Chicago, Illinois, United States
Indiana Univ Hosp — Indianapolis, Indiana, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp — Baltimore, Maryland, United States
Univ of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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