A Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy
Combining two nucleoside drugs has the theoretical advantage of optimal protection against
the evolution of resistant strains of HIV. However, one major problem with combination
nucleoside therapy in patients with advanced disease is the increased toxicity resulting
from such therapy. One approach to minimize toxicity while perhaps retaining some of the
benefits of combination therapy is to alternate the two drugs.
Patients are randomized to one of three treatment arms: AZT plus ddI, AZT plus ddC, and AZT
alone alternating monthly with ddI. Half of the patients receiving AZT alternating monthly
with ddI will start with AZT, while the other half will start with ddI. Treatment continues
until death or termination of the study. Patients are followed every 4 weeks. The study will
include a subset of patients for whom virologic, pharmacokinetic, and macroneurologic
assessments will be made.
Interventional
Primary Purpose: Treatment
WK Henry
Study Chair
United States: Federal Government
ACTG 193
NCT00001029
May 1993
Name | Location |
---|---|
USC CRS | Los Angeles, California 90033 |
Stanford CRS | Palo Alto, California 94305 |
Ucsd, Avrc Crs | San Diego, California |
Ucsf Aids Crs | San Francisco, California |
Santa Clara Valley Med. Ctr. | San Jose, California 95128 |
San Mateo County AIDS Program | San Mateo, California 94305 |
Harbor-UCLA Med. Ctr. CRS | Torrance, California 90502 |
University of Colorado Hospital CRS | Aurora, Colorado 80262 |
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 |
Massachusetts General Hospital ACTG CRS | Boston, Massachusetts 02114 |
Beth Israel Deaconess - East Campus A0102 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 |
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 |
Univ. of Cincinnati CRS | Cincinnati, Ohio 45267 |
Case CRS | Cleveland, Ohio 44106 |
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 |