Objective: To evaluate the efficacy and safety of zidovudine (ZDV) and lymphoblastoid interferon (IFN)-alpha combination therapy compared with ZDV monotherapy in HIV-infected subjects with CD4+ cell counts between 150 and 500 x 10(6)/l.
Design: Open, randomized controlled trial with subjects stratified by the Centers for Disease Control and Prevention (CDC) 1986 classification of HIV disease (group II/III or IV). The study was amended to a sequential design in February 1992 to allow interim analyses to be conducted.