RESULTS OF A DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE DOUBLE-STRANDED-RNA DRUG POLYI-POLYC(12)U IN THE TREATMENT OF HIV-INFECTION

In this multicenter, randomized, double-blind study the activity of po lyI:polyC(12)U administered with zidovudine was evaluated in the treat ment of HIV infection. Thirty-six HIV-positive, pre-AIDS individuals ( 100-500 CD4(+) cells/mm(3)) who had had at least six months of zidovud ine therapy received polyI:polyC(12)U (400 or 700 mg) or placebo twice weekly with zidovudine, PolyI:polyC(12)U subjects with baseline CD4() counts greater than or equal to 300/mm(3) showed a trend towards red uced CD4(+) loss versus placebo recipients. PolyI:polyC(12)U subjects were more likely to exhibit positive delayed-type hypersensitivity res ponses than placebo recipients. Placebo subjects crossing over to poly I:polyC(12)U therapy demonstrated improved CD4(+) and delayed-type hyp ersensitivity responses. PolyI:polyC(12)U subjects with baseline CD4() counts greater than or equal to 300/mm(3) were less likely to develo p AIDS than similar placebo subjects. PolyI:polyC(12)U therapy of HIV- positive subjects restored or stabilized immune function as indexed by delayed-type hypersensitivity reactivity and, in individuals with CD4 (+) counts > 300/mm(3), abrogated CD4(+) loss and reduced disease prog ression, PolyI:polyC(12)U was generally well-tolerated in this zidovud ine-treated population, No subject discontinued therapy due to an adve rse reaction or aberrant laboratory parameter.