BETHESDA, Md--A two-drug combination used as initial therapy has proven
more effective in limiting disease progression or death in children with
symptomatic HIV disease than didanosine (ddI, Videx) alone.
The multicenter trial of zidovudine (AZT, Retrovir) combined with either
lamivudine (3TC, Epivir) or ddI was terminated early when results indicated
the superiority of combination antiretroviral therapy, particularly for
children under age 3 who had never been treated with anti-HIV drugs, the
National Institutes of Health announced.
The randomized, double-blind phase I/II study, known as AIDS Clinical
Trials Group (ACTG) 300, began in July 1995 and was conducted at 87 centers
in the United States. It included 615 HIV-infected infants and children,
aged 42 days to 15 years at the time of enrollment, with 53% younger than
Data from 596 patients were included in a preliminary analysis presented
to the study's independent data and safety monitoring board on June 18.
These included 236 patients on AZT/3TC, 235 on ddI alone, and 125 on AZT/ddI.
The trial's primary clinical outcomes were disease progression and survival.
Analyses of data from the three treatment groups indicated that both of
the combination therapies significantly improved survival and delayed disease
progression, compared with ddI alone. As a result, the monitoring board
recommended early termination of the trial.
"The preliminary results clearly demonstrate that combination therapy
can significantly slow disease progression and reduce the risk of death
in HIV-infected children, as is the case in adults," said Anthony
S. Fauci, MD, director of the National Institute of Allergy and Infections
Diseases, which co-funded the study with the National Institute of Child
Health and Human Development.