Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
NCT ID: NCT00000636
Last Updated: 2021-11-02
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
2000 participants
INTERVENTIONAL
1997-10-31
Brief Summary
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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.
Detailed Description
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After baseline screening, patients are randomized to one of two treatment arms and are evaluated by means of clinic visits monthly for the first three months, then every three months for the first year (there are additional clinic visits for INH patients). Patients are then evaluated every six months. One group of patients takes INH plus vitamin B6 for 12 months. The other group of patients takes 1 of 2 doses of rifampin (depending on patient's weight) plus pyrazinamide in 3-4 divided doses for 60 days.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Isoniazid
Pyrazinamide
Pyridoxine hydrochloride
Rifampin
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
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
Brown LS
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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Gordin F, Matts J, Miller C, Chaisson R, Garcia M, O'Brien R. Risk factors for developing active tuberculosis (TB) among HIV-infected, PPD-positive (+) patients (pts). Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:151 (abstract no 448)
New TB guidelines for persons with HIV. AIDS Treat News. 1998 Nov 6;(No 306):6.
Gordin F, Chaisson RE, Matts JP, Miller C, de Lourdes Garcia M, Hafner R, Valdespino JL, Coberly J, Schechter M, Klukowicz AJ, Barry MA, O'Brien RJ. Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS, the Adult AIDS Clinical Trials Group, the Pan American Health Organization, and the Centers for Disease Control and Prevention Study Group. JAMA. 2000 Mar 15;283(11):1445-50. doi: 10.1001/jama.283.11.1445.
Other Identifiers
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TB/PPD+
Identifier Type: -
Identifier Source: secondary_id
ACTG 177
Identifier Type: -
Identifier Source: secondary_id
11556
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 004
Identifier Type: -
Identifier Source: org_study_id