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)
The rapid emergence of resistant HIV strains has been observed in patients receiving
monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use
of combination therapy with two nucleoside drugs or convergent combination therapy with two
nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant
HIV strains. Since toxicity is a major problem in patients with advanced disease who are
receiving combination nucleoside therapy, alternating the two drugs may provide a way of
retaining several benefits of combination therapy while minimizing the increased toxicity.
Patients are randomized to receive either AZT/ddC, AZT/ddI, AZT alternating monthly with
ddI, or AZT/ddI/nevirapine. Patients are evaluated at week 0 and every 4 weeks thereafter
for 2 years. Pharmacologic, virologic, and macroneurologic substudies will be conducted.
Patients who are already enrolled on protocol ACTG 193 will be given the option of
continuing on their originally assigned ACTG 193 therapy for an additional 6 months or
undergoing re-randomization to one of the four treatment arms on ACTG 193A.
Interventional
Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Henry WK
Study Chair
United States: Federal Government
ACTG 193A
NCT00000781
September 1996
Name | Location |
---|---|
San Francisco Gen Hosp | San Francisco, California 941102859 |
Bellevue Hosp / New York Univ Med Ctr | New York, New York 10016 |
Mem Sloan - Kettering Cancer Ctr | New York, New York 10021 |
Univ of Rochester Medical Center | Rochester, New York 14642 |
Julio Arroyo | West Columbia, South Carolina 29169 |
Univ of California / San Diego Treatment Ctr | San Diego, California 921036325 |
San Francisco AIDS Clinic / San Francisco Gen Hosp | San Francisco, California 941102859 |
Stanford at Kaiser / Kaiser Permanente Med Ctr | San Francisco, California 94115 |
Olive View Med Ctr | Sylmar, California 91342 |
Harbor UCLA Med Ctr | Torrance, California 90502 |
Univ of Colorado Health Sciences Ctr | Denver, Colorado 80262 |
Univ of Miami School of Medicine | Miami, Florida 331361013 |
Rush Presbyterian - Saint Luke's Med Ctr | Chicago, Illinois 60612 |
Northwestern Univ Med School | Chicago, Illinois 60611 |
Indiana Univ Hosp | Indianapolis, Indiana 462025250 |
Harvard (Massachusetts Gen Hosp) | Boston, Massachusetts 02114 |
Beth Israel Deaconess - West Campus | Boston, Massachusetts 02215 |
Boston Med Ctr | Boston, Massachusetts 02118 |
Univ of Minnesota | Minneapolis, Minnesota 55455 |
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | Bronx, New York 10461 |
Jack Weiler Hosp / Bronx Municipal Hosp | Bronx, New York 10465 |
Bronx Veterans Administration / Mount Sinai Hosp | Bronx, New York 10468 |
Montefiore Med Ctr / Bronx Municipal Hosp | Bronx, New York 10467 |
SUNY / Erie County Med Ctr at Buffalo | Buffalo, New York 14215 |
City Hosp Ctr at Elmhurst / Mount Sinai Hosp | Elmhurst, New York 11373 |
Cornell Univ Med Ctr | New York, New York 10021 |
Mount Sinai Med Ctr | New York, New York 10029 |
SUNY / State Univ of New York | Syracuse, New York 13210 |
Univ of North Carolina | Chapel Hill, North Carolina 275997215 |
Med College of Ohio | Toledo, Ohio 43699 |
Milton S Hershey Med Ctr | Hershey, Pennsylvania 170330850 |
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | Knoxville, Tennessee 37920 |
Univ of Washington | Seattle, Washington 98105 |
Great Lakes Hemophilia Foundation | Milwaukee, Wisconsin 53233 |
Univ of South Florida | Tampa, Florida 33612 |
St Louis Regional Hosp / St Louis Regional Med Ctr | St Louis, Missouri 63112 |
Columbus Children's Hosp | Columbus, Ohio 432052696 |
Univ of Alabama at Birmingham | Birmingham, Alabama 35294 |
Univ of Southern California / LA County USC Med Ctr | Los Angeles, California 900331079 |
Cook County Hosp | Chicago, Illinois 60612 |
Hennepin County Med Clinic | Minneapolis, Minnesota 55415 |
St Paul Ramsey Med Ctr | St Paul, Minnesota 55101 |
Univ of Nebraska Med Ctr | Omaha, Nebraska 681985130 |
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp | Bronx, New York 10461 |
Montefiore Family Health Ctr / Bronx Municipal Hosp | Bronx, New York 10461 |
Samaritan Village Inc / Bronx Municipal Hosp | Bronx, New York 10461 |
Comprehensive Health Care Ctr / Bronx Municipal Hosp | Bronx, New York 10461 |
North Central Bronx Hosp / Bronx Municipal Hosp | Bronx, New York 10467 |
Beth Israel Med Ctr | New York, New York 10003 |
Saint Clare's Hosp and Health Ctr | New York, New York 10019 |
Moses H Cone Memorial Hosp | Greensboro, North Carolina 27401 |
Univ of Cincinnati | Cincinnati, Ohio 452670405 |
Girard Med Ctr | Philadelphia, Pennsylvania 191046073 |
Thomas Jefferson Univ Hosp | Philadelphia, Pennsylvania 191075098 |
Univ of Pennsylvania at Philadelphia | Philadelphia, Pennsylvania 19104 |
Children's Hosp of Los Angeles | Los Angeles, California 90027 |
Huntington Memorial Hosp / Children's Hosp of Los Angeles | Pasadena, California 91105 |
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | San Jose, California 951282699 |
Stanford Univ Med Ctr | Stanford, California 943055107 |
San Mateo AIDS Program / Stanford Univ | Stanford, California 943055107 |
Mountain States Reg Hemo Ctr / Univ of Colorado | Denver, Colorado 80262 |
Denver Dept of Health and Hosps | Denver, Colorado 80262 |
Rose Med Ctr | Denver, Colorado 80262 |
Yale Univ / New Haven | New Haven, Connecticut 065102483 |
Howard Univ | Washington, District of Columbia 20059 |
Georgetown Univ Med Ctr | Washington, District of Columbia 20007 |
Whitman - Walker Clinic / Georgetown Univ Med Ctr | Washington, District of Columbia 200072197 |
HIV Ctr - District of Columbia Gen Hosp | Washington, District of Columbia 200072197 |
George Washington Univ / Hershey Med Ctr | Washington, District of Columbia 20037 |
Univ of Hawaii | Honolulu, Hawaii 96816 |
Louis A Weiss Memorial Hosp | Chicago, Illinois 60640 |
Methodist Hosp of Indiana / Life Care Clinic | Indianapolis, Indiana 46202 |
Univ of Louisville / East Tennesee Comprehensive Hem Ctr | Louisville, Kentucky 40202 |
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial | Worcester, Massachusetts 01605 |
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts | Lebanon, New Hampshire 03756 |
Robert Wood Johnson Med School / Hershey Med Ctr | New Brunswick, New Jersey 08903 |
Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark, New Jersey 071032714 |
Adirondack Med Ctr at Saranac Lake | Albany, New York 122083479 |
Albany Med College / Division of HIV Medicine A158 | Albany, New York 122083479 |
Mid - Hudson Care Ctr | Albany, New York 122083479 |
Montefiore Med Ctr Adolescent AIDS Program | Bronx, New York 10467 |
SUNY / Health Sciences Ctr at Brooklyn | Brooklyn, New York 112032098 |
North Shore Univ Hosp | Manhasset, New York 11030 |
Mount Sinai Med Ctr / Hemophilia Treatment Ctr | New York, New York 10029 |
Harlem Hosp Ctr | New York, New York 10037 |
Columbia Presbyterian Med Ctr | New York, New York 100323784 |
Univ of Kentucky Lexington | Cincinnati, Ohio 45267 |
MetroHealth Med Ctr | Cleveland, Ohio 441091998 |
Case Western Reserve Univ | Cleveland, Ohio 44106 |
Saint Michael's Med Ctr / Milton S Hershey Med Ctr | Hershey, Pennsylvania 170330850 |
Med Univ of South Carolina / UNC | Charleston, South Carolina 29425 |
Meharry Med College | Nashville, Tennessee 37203 |
Univ of Texas Galveston | Galveston, Texas 775550435 |
Univ Texas Health Science Ctr / Univ Texas Med School | Houston, Texas 77030 |
Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp | Green Bay, Wisconsin 54301 |