Human immunodeficiency virus type 1 infection, clinical trials and ethics in paediatrics.
Children are not little adults and questions regarding their treatment must be directly addressed to children. Phase I and II trials should closely follow those in adults, integrated by separate studies in infants. Phase III trials should be carried out in a parallel fashion, flexible enough to be modifiable according to results from larger studies in adults. On condition that study designs are ethically impeccable and are respectful of the intrinsic social weakness of children, as many children as possible should enter clinical trials to offer wide access to drugs and ensure that questions are addressed as rapidly and efficiently as possible.
de Martino
M
M
Institute of Paediatrics and Obstetrics, University of Chieti, Italy.
Galli
L
L
Guarino Amato
A
A
Vierucci
A
A
D000293:Adolescent; D000328:Adult; D001942:Breast Feeding; D002648:Child; D002986:Clinical Trials as Topic / Q000592:standards; D004992:Ethics, Medical; D005260:Female; D015658:HIV Infections / Q000628:therapy / Q000635:transmission; D015497:HIV-1; D006801:Humans; D018445:Infectious Disease Transmission, Vertical; D007258:Informed Consent; D018579:Patient Selection; D010372:Pediatrics / Q000592:standards; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012306:Risk; D015819:Substance Abuse, Intravenous