Design of antiretroviral clinical trials for HIV-1 infected pregnant women and their newborn infants

Abstract

Antiretroviral therapy has been highly successful in reducing mother to child transmission of human immunodeficiency virus-1 infection in pregnant women. However, the treatment regimens are intensive, difficult to deliver in less developed countries, and there are limited pharmacology studies addressing critical questions regarding maternal safety and fetal risk. There are currently 3 pharmacologically diverse classes of antiretroviral agents with inadequate information available to define drug disposition necessary to determine appropriate dose regimens and limited data on long-term adverse events. This article summarizes representative clinical studies for selected antiretrovirals that provide a framework for continuing the necessary clinical research to extend successful outcomes in developed countries to human immunodeficiency virus-1 infected pregnant women and infants world-wide and minimize the risk of long-term adverse effects.