Prophylaxis 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 effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.

Key facts

Study ID

NCT00000636

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2000

Expected to finish

1997-10-01

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/malignancy.
• Aminoglycosides, quinolones or fluoroquinolones such as ciprofloxacin or ofloxacin for < 14 days for treatment of intercurrent infection.
• Patients must have:
• HIV infection.
• Signed informed consent.
• Reasonably good health at time of study entry.
• Perceived life expectancy of at least six months.
• 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.
• Prior Medication:
• Allowed:
• 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 tuberculosis (confirmed or suspected).
• Sensitivity or intolerance to study medication.
• Acute hepatitis.
• Evidence of peripheral neuropathy, i.e., signs or symptoms of paresis, paresthesias, neuromotor abnormalities, or neurosensory deficits of grade 3 or worse.
• Inability to have concomitant medications changed to avoid serious interaction with study drug.
• 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 antituberculous activity should be avoided, including the following:
• Aminosalicylic acid salts, capreomycin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, pyrazinamide, rifabutin, rifampin, streptomycin, and thiacetazone.
• Prior Medication:
• Excluded:
• History of treatment for > 2 months with agents that have known or potential antituberculous activity other than those specifically allowed.
• Agents with potential or known antituberculous activity include the following:
• Aminoglycosides such as amikacin, aminosalicylic acid salts, capreomycin, ciprofloxacin, clofazimine, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, ofloxacin, pyrazinamide, quinolones or fluoroquinolones, rifabutin, rifampin, streptomycin, and thiacetazone.
• Patients may not have:
• Current active tuberculosis.
• Acute hepatitis.
• Peripheral neuropathy of grade 3 or grade 4.
• Willing and able, in the clinician's opinion, to comply with the treatment and clinical management issues.

Where it is running

• Community Consortium / UCSF — 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
• Chicago Dept of Health / Speciality STD Clinic — Chicago, Illinois, United States
• AIDS Research Alliance - Chicago — Chicago, Illinois, United States
• Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
• Johns Hopkins Univ / Brazil — Baltimore, Maryland, United States
• Johns Hopkins Univ / School of Hygiene & Public Health — Baltimore, Maryland, United States
• Boston Dept of Health and Hosps — Boston, Massachusetts, United States
• Comprehensive AIDS Alliance of Detroit — Detroit, Michigan, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Southern New Jersey AIDS Cln Trials / Dept of Med — Camden, New Jersey, United States
• Saint Michael's Med Ctr — Newark, New Jersey, United States
• Lattimore Comprehensive Pulmonary Disease Clinic — Newark, New Jersey, 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
• Beth Israel Med Ctr — 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
• Philadelphia FIGHT — Philadelphia, Pennsylvania, United States
• Richmond AIDS Consortium — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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