|
Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection Clinical research trials and Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection. Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection clinical trial. Participants frequently get the best healthcare available for their Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection  Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
For Condition: HIV Infections,Tuberculosis
Status: Completed
Sponsor(s): Hoechst Marion Roussel , Lederle Laboratories,National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: 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.
Details: 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. 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.
Eligibility:
Study Type: Interventional, Prevention, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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.
Total Enrollment: 2000
Location and Contact Information:
Overall Study Official:
ChaissonR, Study Chair,
North Shore Univ Hosp
Manhasset, New York, 11030
United States
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10025
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 112032098
United States
Mid - Hudson Care Ctr
Albany, New York, 122083479
United States
Albany Med College / Division of HIV Medicine A158
Albany, New York, 122083479
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Girard Med Ctr
Philadelphia, Pennsylvania, 191046073
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Wake County Dept of Health
Raleigh, North Carolina, 27610
United States
Meharry Med College
Nashville, Tennessee, 37203
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
HIV Ctr - District of Columbia Gen Hosp
Washington D.C., District of Columbia, 200072197
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Houston Clinical Research Network
Houston, Texas, 77266
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Whitman - Walker Clinic / Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 200072197
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Olive View Med Ctr
Sylmar, California, 91342
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, 60611
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Interfaith Med Ctr
Brooklyn, New York, 112032098
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Med Univ of South Carolina / UNC
Charleston, South Carolina, 29425
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Adirondack Med Ctr at Saranac Lake
Albany, New York, 122083479
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Nassau County Med Ctr
East Meadow, New York, 11554
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Additional Information:
Study ID Numbers: ACTG 177; CPCRA 004,TB/PPD+
Study Start Date:
Record last reviewed: May 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000638
Other Tuberculosis Studies:
1. A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
2. A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
3. The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
4. A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
5. Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)
Related Studies:
Other Tuberculosis Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
|
|
|
|
|
|
|
|
