Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
NCT ID: NCT00000638
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
1999-09-30
Brief Summary
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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.
Detailed Description
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Patients are chosen by a random selection process to either the INH or the rifampin / pyrazinamide arm of the dose. Patients on the INH arm receive INH plus vitamin B6 (pyridoxine hydrochloride ) daily for 12 months. Patients on the other arm receive rifampin plus pyrazinamide for 60 days. Dosage of rifampin and pyrazinamide depends on weight of patient.
Conditions
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Keywords
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Study Design
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PARALLEL
PREVENTION
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.
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.
Exclusion Criteria
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.
13 Years
ALL
No
Sponsors
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Hoechst Marion Roussel
INDUSTRY
Lederle Laboratories
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Chaisson R
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
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
Johns Hopkins Hosp
Baltimore, Maryland, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States
Mid - Hudson Care Ctr
Albany, New York, United States
Interfaith Med Ctr
Brooklyn, New York, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Nassau County Med Ctr
East Meadow, New York, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, United States
North Shore Univ Hosp
Manhasset, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Saint Clare's Hosp and Health Ctr
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
SUNY - Stony Brook
Stony Brook, New York, United States
SUNY / State Univ of New York
Syracuse, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
The Bronx, New York, United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, United States
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, United States
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, United States
Wake County Dept of Health
Raleigh, North Carolina, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Univ of Kentucky Lexington
Cincinnati, Ohio, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
MetroHealth Med Ctr
Cleveland, Ohio, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States
Girard Med Ctr
Philadelphia, Pennsylvania, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina / UNC
Charleston, South Carolina, United States
Julio Arroyo
West Columbia, South Carolina, United States
Meharry Med College
Nashville, Tennessee, United States
Univ of Texas Galveston
Galveston, Texas, United States
Houston Clinical Research Network
Houston, Texas, United States
Univ of Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Halsey N, et al. Twice weekly INH vs RIF and PZA for TB prophylaxis in HIV infected adults. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:55
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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CPCRA 004
Identifier Type: -
Identifier Source: secondary_id
TB/PPD+
Identifier Type: -
Identifier Source: secondary_id
11152
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 177
Identifier Type: -
Identifier Source: org_study_id