COMBINATION THERAPY WITH DIDANOSINE AND INTERFERON-ALPHA IN HUMAN IMMUNODEFICIENCY VIRUS-INFECTED PATIENTS - RESULTS OF A PHASE I II TRIAL/

A nonrandomized trial was undertaken to evaluate the combination of di danosine and interferon-alpha (IFN-alpha) in human immunodeficiency vi rus (HIV)-infected patients, Thirty-six volunteers with >200 x 10(6) C D4 cells/L received didanosine (one 100-, 250-, or 375-mg sachet twice daily) for at least 6 weeks, following which IFN-alpha (1, 5, 10, or 15 MU/day) was begun. Didanosine (one 375-mg sachet twice daily) was s ubstituted for zidovudine in 14 additional patients who had received I FN-alpha and zidovudine for 7-45 months. Thirty-five patients complete d the 34-week study, Clinical or chemical pancreatitis was the most co mmon (6 patients) dose-limiting toxicity, CD4 cell counts increased wi th didanosine but declined following the addition of IFN-alpha; CD4 ce ll percents tended to increase and remain elevated. Thus, combination therapy with didanosine and IFN-alpha can be safely administered to pa tients with HIV infection, The clinical benefit of this combination th erapy will require further evaluation.