Davey V, Cefali F, Metcalf JA, Masur H, Fauci AS, Lane HC; International Conference on AIDS.

Int Conf AIDS. 1990 Jun 20-23; 6: 139 (abstract no. Th.B.22).

National Institutes of Health, Bethesda, Maryland, USA

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 Seven patients have withdrawn because of inability to subjectively tolerate the assigned medication (3 Z, 1 IFN, 3 Z + IFN): Common subjective complaints include fatigue (58% Z, 77% IFN,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.

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• CD4 Lymphocyte Count
• CD4-Positive T-Lymphocytes
• Clinical Trials as Topic
• HIV Infections
• HIV Seropositivity
• Humans
• Interferon Type I, Recombinant
• Interferon-alpha
• Treatment Outcome
• Zidovudine

Other ID:

• 10002290

UI: 102181630

From Meeting Abstracts