Remick S, Follansbee S, Olson R, Pollard R, Reiter W, Salgo M; International Conference on AIDS.

Int Conf AIDS. 1993 Jun 6-11; 9: 488 (abstract no. PO-B26-2115).

Albany Med. Ctr., NY.

OBJECTIVE: To evaluate the safety and tolerance of ddC in the treatment of patients with AIDS or advanced ARC who have had less than 3 months of prior zidovudine (ZDV) therapy. METHODS: 635 patients with AIDS or ARC who had previously received less than 3 months of ZDV therapy were entered in this multicenter, double-blind, placebo-controlled, comparative, two-year trial. Based on the results of initial dose-ranging studies, 320 patients were randomly assigned to receive ddC 0.75 mg q8h and 315 were randomized to receive ZDV 200 mg q4h. The ZDV dosage was changed to 100 mg q4h following approval of the lower dose by the Food and Drug Administration. The safety of ddC was evaluated by comparing the incidence of clinical adverse events, marked laboratory abnormalities, hematologic toxicities, premature withdrawals, and deaths in patients receiving ddC vs those receiving ZDV. RESULTS: In the ddC treatment group, the most common clinical adverse events (excluding peripheral neuropathy) included oral ulcers, headache, fatigue, and rash, while in the ZDV group the most common adverse events included nausea, headache, and fatigue. ddC had less hematologic toxicity than ZDV, with grade 3-4 anemia 5.6% vs 15.6% for ZDV, and granulocytopenia 10% vs 24.1% for ZDV. Moderate to severe peripheral neuropathy considered to be possibly or probably related to test treatment developed in 23.1% in the ddC treatment group and 6.0% in the ZDV treatment group. Peripheral neuropathy was the most common reason for premature withdrawal from the study for patients taking ddC and hematologic toxicity was the most common reason for premature withdrawal in the ZDV group. Three patients in the ddC group developed pancreatitis during treatment, one of which was considered to be probably related to treatment, while one patient in the ZDV group developed pancreatitis considered to be unrelated to trial treatment. Fifteen patients in the ddC group and thirteen patients in the ZDV group died either during the study or within the 28-day window after stopping trial treatment, but no deaths were considered to be related to study drugs. CONCLUSIONS: ddC exhibited a safety profile different from that of ZDV, and both drugs were generally well tolerated for the duration of the study period. Peripheral neuropathy was the dose-limiting adverse event observed with ddC treatment but with careful monitoring and dosage adjustment when necessary, irreversible sequelae were avoided in most cases.

Publication Types:

• Meeting Abstracts

Keywords:

• AIDS-Related Complex
• Acquired Immunodeficiency Syndrome
• Blindness
• Clinical Trials as Topic
• Double-Blind Method
• Humans
• Immune Tolerance
• Incidence
• Safety
• Zalcitabine
• Zidovudine
• immunology

Other ID:

• 93335732

UI: 102205110

From Meeting Abstracts