WASHINGTON--The AZT alone arm has been dropped from a large ongoing
federal study of children with HIV infection, because it proved
less effective in preventing disease progression than the other
arms and had significant adverse effects.
The study, begun in August, 1991, has enrolled more than 800 children
and was planned to continue until all children had been treated
for 2 years. However, an interim review by an independent safety
committee led officials to stop the AZT (zidovudine, Retrovir)
arm of the study.
In the children receiving AZT alone, the disease was progressing
more rapidly, based on development of opportunistic infections,
failure to grow, neurological deterioration, and death.
Patients were originally randomized to receive AZT alone, didanosine
(ddI, Videx) alone, or a combination of the two. The other two
arms of the study are continuing, and, to date, no significant
differences have been seen between these two treatment regimens.
The study, cosponsored by the National Institute of Allergy and
Infectious Diseases and the National Institute of Child Health
and Human Development, is under the direction of Drs. Carol J.
Baker and Janet Englund, of Baylor College of Medicine, Houston.