Phase II trial of alternating and intermittent regimens of zidovudine (ZDV) and 2',3'-dideoxycytidine (ddC) in ARC and AIDS.

Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.

Phase II trial of alternating and intermittent regimens of zidovudine (ZDV) and 2',3'-dideoxycytidine (ddC) in ARC and AIDS.

Int Conf AIDS. 1990 Jun 20-23;6(1):139 (abstract no. Th.B.23). Unique Identifier : AIDSLINE ICA6/10002390
Skowron G; Merigan TC; Roger Williams General Hospital, Providence, RI, USA

Abstract: OBJECTIVE: To determine the efficacy and toxicity of alternating and intermittent regimens of ZDV 200 mg q4h and low dose (0.01 mg/kg q4h) or high dose (0.03 mg/kg q4h) ddC compared with continuous ZDV alone in ARC and AIDS. METHODS: Patients were stratified according to CD4 cell numbers greater than or less than or equal to 200 and randomized to one of 7 oral regimens: weekly alternating ZDV and low (A) or high (B) dose ddC; monthly alternating ZDV and low (C) or high (D) dose ddC; intermittent weekly ZDV (E) or high dose ddC (F); continuous ZDV (G). All participants had serum p24 antigen greater than 70 pg/ml. Study drug dosing is to continue for 52 weeks. RESULTS: 131 patients (96 ARC, 35 AIDS) were entered: 90 remain active; 41 have discontinued, 8 for ddC toxicity, 2 for ZDV toxicity. Hematologic toxicity was most frequent in the continuous ZDV limb. Peripheral neuropathy occurred in all treatment groups, but was more common in the two high dose ddC weekly regimens, B and F. Preliminary analysis suggests that there may be p24 antigen suppression and sustained CD4 cell enhancement in the alternating limbs (A-D) compared to the intermittent limbs (E,F). CONCLUSION: Preliminary analysis suggests that alternating regimens of ZDV and ddC may reduce toxicity and enhance efficacy of either drug alone.

Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY AIDS-Related Complex/*DRUG THERAPY Comparative Study CD4-Positive T-Lymphocytes Dose-Response Relationship, Drug Drug Evaluation Drug Therapy, Combination Human Leukocyte Count Random Allocation Zalcitabine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT
901230
M90C3695

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