ACTG 330--SAFETY & PHARMACOKINETICS OF 1592U89 ALONE VS COMBINATION--PEDIATRIC

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Zidovudine (ZDV), didanosine (ddI), stavudine (d4T), and lamivudine (3TC), are commonly used as single agents as well as in combination for treatment of HIV infection in children. Accumulating information suggests that combination therapy with two or more antiretroviral agents, however, may hold more promise than single-agent therapy in the long term management of HIV infection. In addition, as resistance to common medications occurs, it becomes increasingly important to investigate new medications that may be used to treat HIV-infected infants and children. 1592u89 is a nucleoside analog with activity against HIV similar to that of ZDV. In vitro studies of this new medication suggest that resistance to HIV is slow to emerge, and cross-resistance to other antiretrovirals rare; further 1592u89 may act synergistically to ddI, 3TC, and d4T. Early adult and pediatric studies demonstrated few toxicities with significant reduction in HIV viral load.