Protease inhibitors in combination with other antiretroviral drugs may help reduce the rate of perinatal transmission of HIV-1. During the intrapartum period, no RTV is given after the onset of active labor. During the postpartum period, RTV is begun as soon as oral intake is allowable following delivery. During the postpartum period, Combivir may be resumed. Infants begin 3TC and ZDV as soon as oral intake is tolerated.
Infants participate in one of two cohorts.
The dosing schedule is based on Cohort 1 drug pharmacokinetics data. Both maternal and infant blood is drawn to assess drug pharmacokinetics. Cervical secretions are collected to assess presence of virus. In addition, all placentas are examined by histopathology to determine the role of placenta on preterm delivery in women receiving combination antiretroviral therapy. I A phase one trial is the first step on a drug's journey to approval.