Combination zidovudine and dideoxyinosine in asymptomatic HIV(+) patients.

Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.

Combination zidovudine and dideoxyinosine in asymptomatic HIV(+) patients.

Int Conf AIDS. 1992 Jul 19-24;8(1):Mo15 (abstract no. MoB 0055). Unique Identifier : AIDSLINE ICA8/92400010
Ragni M; Dafni R; Amato DA; Korvick J; Merigan TC; Univ. of Pittsburgh, PA.

Abstract: OBJECTIVES: Longterm antiretroviral therapy may be limited by toxicity and resistance. In order to evaluate whether potentially synergistic drug combinations may reduce drug toxicity and delay resistance, we conducted a Phase I/II open label, randomized trial of combination ZDV and ddI in 116 asymptomatic HIV(+) individuals. METHODS: Patients were randomized to 1 of 4 arms including low-dose (ZDV 150 mg and ddI 134 mg daily), moderate-dose (ZDV 300 mg and ddI 334 mg daily), or high-dose combination (ZDV 600 mg and ddI 500 mg daily) or ddI alone (ddI 500 mg daily). Patients were stratified at entry for CD4 and prior zidovudine treatment. All patients had CD4 between 200 and 500/mm3. RESULTS: At 24 weeks followup, combination ZDV and ddI was well tolerated with only one episode of neuropathy and no pancreatitis. No endpoints were reached. Other grade 3, 4 toxicities included liver function abnormalities (LFT) in 16, amylase elevation in 3, myelotoxicity in 2, and nausea and/or vomiting in 1. Liver toxicity was more common in hemophiliacs than nonhemophiliacs, 9 of 38 vs. 7 of 85, chi 2 = 4.186, p less than .05. CD4 counts increased from week 0 to week 24, and did not differ among the 4 arms. The mean CD4 at week 0 was 340/mm3 and at week 24 was 404/mm3. Serial quantitative viral cultures have shown decrease in viral titer. CONCLUSION: Combination ZDV and ddI is well tolerated with the exception of greater frequency of LFT toxicity in hemophilia patients. Antiviral activity, as measured by CD4 count, is observed for all three dose combinations as well as ddI alone. The optimal dosage combination of ZDV and ddI remains unknown.

Keywords: Bone Marrow Diseases/CHEMICALLY INDUCED CD4-Positive T-Lymphocytes Didanosine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE Drug Therapy, Combination Hemophilia/COMPLICATIONS Human HIV Infections/COMPLICATIONS/*DRUG THERAPY Leukocyte Count Liver Diseases/CHEMICALLY INDUCED Nausea/CHEMICALLY INDUCED Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT
921230
M92C5337

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