Date: Wed, 15 Feb 1995 21:28:49 +0500
From: awilson@smtpinet.aspensys.com (Wilson, Anne)

     
P R E S S   R E L E A S E
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National Institutes of Health
Public Health Service
Monday, Feb. 13, 1995


Interim Results Lead to Discontinuation of AZT-Only Study Arm

      Interim results of a study comparing three treatments for
children with symptomatic HIV infection or AIDS showed that
zidovudine (AZT) alone was the least effective as an initial therapy to
prevent disease progression.  The children receiving AZT as a single
agent also had higher rates of side effects. 

      The trial, AIDS Clinical Trials Group (ACTG) 152 compares
AZT alone, didanosine (ddI) alone and a combination of AZT and ddI
in children with AIDS aged 3 months to 18 years who had received
little or no prior antiretroviral treatment.  Investigators will 
continue the study without the single agent AZT arm.

      The study is a collaborative effort by the Pediatric ACTG of the
National Institute of Allergy and Infectious Diseases and the National
Institute of Child Health and Human Development.  The study's
protocol chairs are Carol J. Baker, M.D., and Janet Englund, M.D., both
from the Baylor College of Medicine, Houston, Texas.  Bristol-Myers
Squibb provided the ddI and the Burroughs Wellcome Co. provided the
AZT for the study.

      An independent data and safety monitoring board reviewed the
interim data from the study and recommended that the single agent AZT
arm be discontinued.  Because differences in disease progression and
side effects between the other two arms were not significant, the ddI and
the ddI/AZT combination arms will continue.  

      "These interim results add to our knowledge base of therapy for
children with HIV disease.  Further clarification of options for treatment
will emerge as additional study data are accumulated and analyzed,"
says Anthony S. Fauci, M.D., NIAID director. 

      Children who received AZT alone will be offered the option of
switching to another therapy or continuing on AZT, whichever is
appropriate for the individual child's condition. 

      Under ACTG 152, neither the doctors nor the patients knew
which therapy each patient received.  However, the monitoring board's
review revealed that the group of children receiving AZT alone had
more rapid rates of disease progression as measured by growth failure,
new opportunistic infections, neurologic and neurodevelopmental
deterioration or death.  The major side effects seen in the study were
blood and other chemical abnormalities.  Children receiving AZT
monotherapy had a significantly higher proportion of these side effects. 

      The study, which opened in August 1991 and enrolled the last
patient in August 1993, includes 839 children, who were 3 months to 18
years when enrolled, with 54 percent of the total aged 3 months to 30
months.  The study is conducted at 35 NIAID-funded sites and 26
NICHD-funded sites and one regional center of the National Hemophilia
Foundation, funded by NIAID.  

      Further analysis of the study, including determination of any
differences in effectiveness and toxicity between treatment with ddI and
with a combination of ddI and AZT, will take place in late 1995 after
the study closes.  

      HIV disease is the fifth leading cause of death in U.S. children
younger than 15 years, according to the National Center for Health
Statistics.  An estimated 10,000 children are infected with HIV in the
United States, with about 1,750 new infections occurring each year.

      NIAID and NICHD, two of the 17 institutes at the National
Institutes of Health, support scientists and scientific studies at
universities, medical schools and research institutions in the United
States and abroad.  NIH is an agency of the U.S. Public Health Service,
part of the Department of Health and Human Services.

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