Multicenter, randomized, double-blind ACTG trial of zidovudine (ZDV) versus dideoxyinosine (ddI) versus a combination of ZDV and ddI, to evaluate the safety, tolerance, and efficacy of the treatment arms. Recently, phase I studies of ddI therapy in both adults and children have indicated improvement in clinical and laboratory parameters. Toxicity associated with ddI has been modest, consisting mainly of pancreatitis and peripheral neuropathy. The bone marrow toxicity associated with ZDV therapy occurs relatively frequently and occasionally results in permanent discontinuation of this drug. Also, apparent HIV-resistance to ZDV is occasionally observed in patients who tolerate therapy and initially respond, but later have progression of disease. The direct comparison of ZDV and ddI therapy in children has not been made. Combination antiviral therapy (ZDV plus ddI) could give added therapeutic benefit to children while limiting the in vivo development of viral resistance. All drugs will be administered orally with clinical and laboratory evaluations performed at specified intervals. Survival and disease progression are the primary endpoints, with secondary endpoints including; clinical, immunologic, virologic and drug associated toxicity or intolerance parameters. These endpoints will be evaluated to assess the efficacy, safety and tolerance of therapy.
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