Completed
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-02
2000
Participants Needed
76
Research Sites
N/A
Total Duration
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
H
Hoechst Marion Roussel
Collaborating Sponsor
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.
CONDITIONS
Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Patients may not have the following prior conditions:
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Total: 76 locations
1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Status Unknown
2
Children's Hosp of Los Angeles
Los Angeles, California, United States, 90027
Status Unknown
3
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Status Unknown
4
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States, 946021018
Status Unknown
5
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
6
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
Status Unknown
7
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Status Unknown
8
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Status Unknown
9
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
10
Olive View Med Ctr
Sylmar, California, United States, 91342
Status Unknown
11
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
Status Unknown
12
Yale Univ / New Haven
New Haven, Connecticut, United States, 065102483
Status Unknown
13
HIV Ctr - District of Columbia Gen Hosp
Washington D.C., District of Columbia, United States, 200072197
Status Unknown
14
Whitman - Walker Clinic / Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States, 200072197
Status Unknown
15
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States, 20007
Status Unknown
16
Howard Univ
Washington D.C., District of Columbia, United States, 20059
Status Unknown
17
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
18
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Status Unknown
19
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
20
Children's Mem Hosp Family Cln / Northwestern Univ Med Schl
Chicago, Illinois, United States, 60611
Status Unknown
21
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
22
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
23
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States, 60640
Status Unknown
24
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
25
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, United States, 212052196
Status Unknown
26
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
27
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Status Unknown
28
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Status Unknown
29
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
30
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
Status Unknown
31
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
32
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
Status Unknown
33
Adirondack Med Ctr at Saranac Lake
Albany, New York, United States, 122083479
Status Unknown
34
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States, 122083479
Status Unknown
35
Mid - Hudson Care Ctr
Albany, New York, United States, 122083479
Status Unknown
36
Interfaith Med Ctr
Brooklyn, New York, United States, 112032098
Status Unknown
37
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 112032098
Status Unknown
38
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
39
Nassau County Med Ctr
East Meadow, New York, United States, 11554
Status Unknown
40
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, United States, 11373
Status Unknown
41
North Shore Univ Hosp
Manhasset, New York, United States, 11030
Status Unknown
42
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
43
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
44
Saint Clare's Hosp and Health Ctr
New York, New York, United States, 10019
Status Unknown
45
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
46
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Status Unknown
47
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
48
Columbia Presbyterian Med Ctr
New York, New York, United States, 100323784
Status Unknown
49
SUNY - Stony Brook
Stony Brook, New York, United States, 117948153
Status Unknown
50
SUNY / State Univ of New York
Syracuse, New York, United States, 13210
Status Unknown
51
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States, 10461
Status Unknown
52
Comprehensive Health Care Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
53
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
54
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
55
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
56
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, United States, 10465
Status Unknown
57
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10467
Status Unknown
58
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States, 10467
Status Unknown
59
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, United States, 10467
Status Unknown
60
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
61
Moses H Cone Memorial Hosp
Greensboro, North Carolina, United States, 27401
Status Unknown
62
Wake County Dept of Health
Raleigh, North Carolina, United States, 27610
Status Unknown
63
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
64
Univ of Kentucky Lexington
Cincinnati, Ohio, United States, 45267
Status Unknown
65
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
66
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
Status Unknown
67
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
68
Girard Med Ctr
Philadelphia, Pennsylvania, United States, 191046073
Status Unknown
69
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
70
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States, 191075098
Status Unknown
71
Med Univ of South Carolina / UNC
Charleston, South Carolina, United States, 29425
Status Unknown
72
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
73
Meharry Med College
Nashville, Tennessee, United States, 37203
Status Unknown
74
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Status Unknown
75
Houston Clinical Research Network
Houston, Texas, United States, 77266
Status Unknown
76
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Status Unknown
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
0
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F Gordin, R E Chaisson, J P Matts...
https://pubmed.ncbi.nlm.nih.gov/10732934