A PILOT-STUDY OF SEQUENTIAL THERAPY WITH ZIDOVUDINE PLUS ACYCLOVIR, DIDEOXYINOSINE, AND DIDEOXYCYTIDINE IN PATIENTS WITH SEVERE HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION

A pilot study was initiated to explore a sequential combination antire troviral regimen in 21 patients with AIDS or advanced human immunodefi ciency virus (HIV) infection, who had received little or no prior anti -HIV therapy. The mean entry CD4 cell count was 184/mm3. Patients rece ived 3-week cycles consisting of zidovudine plus acyclovir, dideoxyino sine, and dideoxycytidine for 1 week each. Overall, the regimen was we ll tolerated for up to 3 years. The principal toxicities were anemia, nausea, and vomiting; 1 patient developed retinal lesions. The mean CD 4 cell count reached a peak of 64 cells/mm3 above baseline at week 8 ( P = .005 compared to baseline) and remained above baseline for >40 wee ks. Patients also gained weight and had decreases in serum HIV p24 ant igen. Eight patients developed opportunistic infections or tumors. Onl y 4 patients died during 3 years of follow-up. This regimen appears to be generally tolerable and to have anti-HIV activity. Additional stud ies will be needed, however, to learn how to best combine the availabl e agents in patients with HIV infection.