Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.
A randomized trial comparing zidovudine, alpha interferon, or the combination in early HIV infection.
Int Conf AIDS. 1990 Jun 20-23;6(1):139 (abstract no. Th.B.22). Unique Identifier : AIDSLINE ICA6/10002290 Davey V; Cefali F; Metcalf JA; Masur H; Fauci AS; Lane HC; National Institutes of Health, Bethesda, Maryland, USA
Abstract:
OBJECTIVES: To compare tolerance and toxicity of administration of zidovudine (Z), alpha interferon (IFN), and the combination of both (Z + IFN) and to determine relative efficacy in delaying progression of HIV disease. METHODS: HIV-infected patients with greater than or equal to 500 CD4 cell/mm3, were randomized to oral Z alone (1200 mg qd), s.c. IFN alone (5 X 10(6) units qd with increases as tolerated), or a combination of Z + IFN (600 mg qd and 1.0 x 10(6) units qd, respectively, with IFN dose increases as tolerated). Study endpoints are decline in CD4 count to less than 200 mm3 or less than 20% of total lymphocytes or development of an AIDS-defining opportunistic infection (OI). RESULTS: Twenty-seven patients have been randomized to Z, 29 to IFN, 28 to Z + IFN. Thirty-five patients have completed greater than or equal to 28 weeks on study. Mean tolerated daily dose(s) at 28 weeks: Z group--1025 mg qd, IFN group--5 x 10(6) units qd, Z + IFN group--600 mg qd and 2 x 10(6) units qd, respectively. Seven patients have withdrawn because of inability to subjectively tolerate the assigned medication (3 Z, 1 IFN, 3 Z + IFN): Common subjective complaints include fatigue (58% Z, 77% IFN, 84% Z + IFN), nausea (71% Z, 18% IFN, 48% Z + IFN), anorexia (29% Z, 45% IFN, 40% Z + IFN). In one patient IFN was discontinued for a grade IV SGOT elevation. Most frequent laboratory toxicities were SGOT greater than 150 units/L (4% Z, 5% IFN, 20% Z + IFN), hemoglobin less than or equal to 12 gm/dl (21% Z, 14% IFN, 32% Z + IFN), granulocytes less than 1000/mm3 (4% Z, 27% IFN, 40% Z + IFN). No patients have reached study endpoints of CD4 cell count decline, CD4% decline, or OI development. CONCLUSIONS: Administration of Z, IFN, or Z + IFN to patients with HIV infection and CD4 counts greater than or equal to 500/mm3 has produced expected side effects and laboratory toxicities. Study attrition rates for all causes are not markedly different among the 3 groups despite the greater frequency of laboratory and subjective toxicities in the Z + IFN group, suggesting that with careful dose adjustment, the 3 treatment regimens are equally tolerable. Data collected over the next 6 months should allow preliminary analysis of the relative effects of each treatment on study endpoints.
Keywords: Combined Modality Therapy Comparative Study CD4-Positive T-Lymphocytes Drug Tolerance Human HIV Infections/*THERAPY Interferon Type I/ADVERSE EFFECTS/*THERAPEUTIC USE Leukocyte Count Random Allocation Zidovudine/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT 901230
M90C3696
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Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.
