A Randomized, Double Blind, Comparative Study of Dideoxycytidine (ddC) Alone or ddC/AZT Combination Versus Zidovudine (ZDV) Alone in Patients With HIV Infection Who Have Received Prior ZDV Therapy
ddC has been shown to demonstrate an antiviral effect. AZT has been shown to significantly
decrease mortality and reduce the frequency of opportunistic infections in patients with
AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and
patients progress with more opportunistic infections and higher mortality rates. Because of
the demonstrated antiviral activity, absence of hematologic toxicity, and lack of cross
tolerance in laboratory studies of ddC, a study to investigate the long-term effectiveness
of ddC in patients with HIV infection who have received AZT therapy is warranted.
Patients are randomly assigned to 1 of 3 treatment groups. In study arm 1, patients receive
AZT plus ddC placebo. In study arm 2, patients receive ddC plus AZT placebo capsules. In
study arm 3, patients receive ddC plus AZT. Patients are seen every other week for first 8
weeks and monthly thereafter. Patients are stratified by HIV disease status, length of time
receiving AZT, and systemic or local Pneumocystis carinii pneumonia (PCP) prophylaxis.
Patients who reach a clinical AIDS-defining endpoint are offered open-label combination
therapy.
Interventional
Masking: Double-Blind, Primary Purpose: Treatment
M Fischl
Study Chair
United States: Federal Government
ACTG 155
NCT00000651
May 1993
Name | Location |
---|---|
UCLA CARE Center CRS | Los Angeles, California 90095 |
USC CRS | Los Angeles, California 90033 |
UCSD Maternal, Child, and Adolescent HIV CRS | San Diego, California 92093 |
Ucsd, Avrc Crs | San Diego, California |
Ucsf Aids Crs | San Francisco, California |
Harbor-UCLA Med. Ctr. CRS | Torrance, California 90502 |
University of Colorado Hospital CRS | Aurora, Colorado 80262 |
Univ. of Miami AIDS CRS | Miami, Florida 33136 |
Northwestern University CRS | Chicago, Illinois 60611 |
Rush Univ. Med. Ctr. ACTG CRS | Chicago, Illinois 60612 |
Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis, Indiana 46202 |
Tulane Hemophilia Treatment Ctr. | New Orleans, Louisiana 70112 |
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | New Orleans, Louisiana 70112 |
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 |
HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston, Massachusetts 02115 |
Brigham and Women's Hosp., Div. of Infectious Disease | Boston, Massachusetts 02115 |
University of Minnesota, ACTU | Minneapolis, Minnesota |
St. Louis ConnectCare, Infectious Diseases Clinic | St Louis, Missouri 63112 |
Washington U CRS | St. Louis, Missouri |
NJ Med. School CRS | Newark, New Jersey |
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 |
NYU Med. Ctr., Dept. of Medicine | New York, New York |
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 |
Duke Univ. Med. Ctr. Adult CRS | Durham, North Carolina 27710 |
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 |
The Ohio State Univ. AIDS CRS | Columbus, Ohio 43210 |
University of Washington AIDS CRS | Seattle, Washington 98122 |
Pitt CRS | Pittsburgh, Pennsylvania 15213 |