Effective, feasible Interventions to prevent perinatal transmission of HIV-
1 in developing nations are an urgent necessity. Scientific issues of conce
rn include a need to identify other effective antiretroviral agents; to def
ine the shortest effective course of therapy; to assess interventions other
than antiretroviral agents; and to investigate interventions that may redu
ce HIV-1 transmission via breastfeeding. Sound scientific design is fundame
ntal to all research studies. Ethical standards must guide such studies and
include the necessity that the problem studied be a health priority in the
host country; that the highest standard of care attainable in the country
be assured to participants; that the health-care resources of the country n
ot be harmed; that the informed consent of participants be obtained; and th
at a process of discussion ensure that a successful intervention will be co
nsidered for implementation. There are circumstances in which a no-antiretr
oviral comparison may be ethically justified.