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.
BETHESDA, Md--A two-drug combination used as initial therapy has provenmore effective in limiting disease progression or death in children withsymptomatic HIV disease than didanosine (ddI, Videx) alone.
The multicenter trial of zidovudine (AZT, Retrovir) combined with eitherlamivudine (3TC, Epivir) or ddI was terminated early when results indicatedthe superiority of combination antiretroviral therapy, particularly forchildren under age 3 who had never been treated with anti-HIV drugs, theNational Institutes of Health announced.
The randomized, double-blind phase I/II study, known as AIDS ClinicalTrials Group (ACTG) 300, began in July 1995 and was conducted at 87 centersin 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 than3 years.
Data from 596 patients were included in a preliminary analysis presentedto 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 ofthe combination therapies significantly improved survival and delayed diseaseprogression, compared with ddI alone. As a result, the monitoring boardrecommended early termination of the trial.
"The preliminary results clearly demonstrate that combination therapycan significantly slow disease progression and reduce the risk of deathin HIV-infected children, as is the case in adults," said AnthonyS. Fauci, MD, director of the National Institute of Allergy and InfectionsDiseases, which co-funded the study with the National Institute of ChildHealth and Human Development.