A Prospective, Randomized, Comparative Study of the Safety and Efficacy of Clarithromycin Versus Rifabutin Versus the Combination of Clarithromycin Plus Rifabutin for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia or Disseminated MAC Disease in HIV-Infected Patients With CD4 Lymphocyte Counts <= 100 Cells/mm3
Persons with advanced stages of HIV are considered to be at particular risk for developing
disseminated MAC disease. The development of an effective regimen for the prevention of
disseminated MAC disease may be of substantial benefit in altering the morbidity and
possibly the mortality associated with this disease and its treatment.
Patients are randomized to receive clarithromycin alone, rifabutin alone, or the two drugs
in combination daily. Patients are evaluated every 4 weeks for the first 8 weeks and every 8
weeks thereafter for the duration of the study. Patients are followed for 24 months. Per
amendment, a pharmacokinetic substudy will be conducted.
Interventional
Primary Purpose: Treatment
Benson CA
Study Chair
United States: Federal Government
ACTG 196
NCT00001030
June 1996
Name | Location |
---|---|
Alabama Therapeutics CRS | Birmingham, Alabama 35294 |
UCLA CARE Center CRS | Los Angeles, California 90095 |
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. | Oakland, California 94609 |
Ucsf Aids Crs | San Francisco, California |
Howard University Hosp., Div. of Infectious Diseases, ACTU | Washington, District of Columbia 20059 |
Univ. of Miami AIDS CRS | Miami, Florida 33136 |
Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu, Hawaii 96816 |
Northwestern University CRS | Chicago, Illinois 60611 |
Rush Univ. Med. Ctr. ACTG CRS | Chicago, Illinois 60612 |
Cook County Hosp. CORE Ctr. | Chicago, Illinois 60612 |
Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis, Indiana 46202 |
Methodist Hosp. of Indiana | Indianapolis, Indiana 46202 |
Univ. of Iowa Healthcare, Div. of Infectious Diseases | Iowa City, Iowa 52242 |
Johns Hopkins Adult AIDS CRS | Baltimore, Maryland 21287 |
Massachusetts General Hospital ACTG CRS | Boston, Massachusetts 02114 |
Beth Israel Deaconess - East Campus A0102 CRS | Boston, Massachusetts 02215 |
Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston, Massachusetts 02215 |
Bmc Actg Crs | Boston, Massachusetts 02118 |
Hennepin County Med. Ctr., Div. of Infectious Diseases | Minneapolis, Minnesota 55455 |
University of Minnesota, ACTU | Minneapolis, Minnesota |
St. Louis ConnectCare, Infectious Diseases Clinic | St Louis, Missouri 63112 |
Washington U CRS | St. Louis, Missouri |
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | Omaha, Nebraska |
SUNY - Buffalo, Erie County Medical Ctr. | Buffalo, New York 14215 |
NY Univ. HIV/AIDS CRS | New York, New York 10016 |
Memorial Sloan-Kettering Cancer Ctr. | New York, New York 10021 |
Cornell University A2201 | New York, New York 10021 |
Beth Israel Med. Ctr. (Mt. Sinai) | New York, New York 10003 |
Univ. of Rochester ACTG CRS | Rochester, New York 14642 |
Unc Aids Crs | Chapel Hill, North Carolina 27599 |
Carolinas HealthCare System, Carolinas Med. Ctr. | Charlotte, North Carolina 28203 |
Regional Center for Infectious Disease, Wendover Medical Center CRS | Greensboro, North Carolina 27401 |
Univ. of Cincinnati CRS | Cincinnati, Ohio 45267 |
Case CRS | Cleveland, Ohio 44106 |
MetroHealth CRS | Cleveland, Ohio |
The Ohio State Univ. AIDS CRS | Columbus, Ohio 43210 |
Hosp. of the Univ. of Pennsylvania CRS | Philadelphia, Pennsylvania 19104 |
University of Washington AIDS CRS | Seattle, Washington 98122 |
Bronx-Lebanon Hosp. IMPAACT CRS | Bronx, New York 10457 |
Chicago Children's CRS | Chicago, Illinois 60611 |
The Children's Hosp. of Philadelphia IMPAACT CRS | Philadelphia, Pennsylvania 19104 |