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(Drug information on didanosine) (ddI, Videx) alone.
The multicenter trial of zidovudine(Drug information on zidovudine) (AZT, Retrovir) combined with either lamivudine(Drug information on 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 3 years.
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.