Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.
Zidovudine vs. alpha interferon vs. the combination in patients with early HIV infection.
Int Conf AIDS. 1992 Jul 19-24;8(1):Mo15 (abstract no. MoB 0052). Unique Identifier : AIDSLINE ICA8/92400014 Lane HC; Herpin B; Banks S; Walker RE; Davey RT; Kovacs J; Polis M; Falloon J; Masur H; National Institutes of Health, Bethesda, MD.
Abstract:
OBJECTIVES: To compare the effects of zidovudine (ZDV), alpha interferon (alpha IFN) and a combination of these 2 drugs in delaying the progression of HIV disease. METHODS: One hundred and eighty HIV infected patients with greater than or equal to 500 CD4 cells/mm3 were randomized to oral ZDV (1200 mg qd with downward adjustment as needed) alone, S.C. alpha IFN (5 x 10(6) units qd with increases as tolerated, or a combination of ZDV + alpha IFN (600 mg qd and 1.0 x 10(6) units qd, respectively, with alpha IFN dose increases as tolerated). Stratification variables were prior ZDV, prior Kaposi's Sarcoma, or both. Study endpoints are decline in CD4 count to less than 200 cell/mm3 or less than 20% of total lymphocytes or development of an AIDS-defining opportunistic infection (OI). Data were analyzed utilizing ANOVA and AUC combined with a one sample Wilcoxon test. RESULTS: Enrollment was completed in August, 1991. Currently, 107 patients remain active on study (at present, mean length of time on study is 16 months)--42 ZDV, 32 ZDV/alpha IFN, 33 alpha IFN. Thirteen patients (1 ZDV, 4 ZDV/alpha IFN, 8 alpha IFN) dropped out prior to receiving study medication. Five patients were declared off study due to severe toxicities (1 ZDV, 1 ZDV/alpha IFN, 3 alpha IFN). Forty-six withdrew for voluntary or other protocol related reasons including subjective intolerance of study medications. No clinical endpoints have been reached. Of the laboratory endpoints, no patients reached CD4 less than 200, but nine patients reached CD4 less than 20% (4 ZDV/alpha IFN, 5 alpha IFN; p = 0.086, intent to treat). Utilizing AUC analysis, while total CD4 counts were significantly decreased in both alpha IFN groups (p = .01), no statistically significant differences have been seen in the analysis of CD4 percents (p = 0.4). CONCLUSIONS: Nine laboratory study endpoints, CD4 less than 20% have occurred in the two alpha IFN groups. No endpoints have occurred in the ZDV alone group. Definitive conclusions of clinical efficacy cannot be made at this time. Evaluation of additional endpoints, along with dosage data analysis and other parameters such as p24 and AZT resistance, may clarify whether differences in efficacy exist between these three groups.
Keywords: Acquired Immunodeficiency Syndrome/COMPLICATIONS Biological Response Modifiers/ADMINISTRATION & DOSAGE/ *THERAPEUTIC USE Combined Modality Therapy Comparative Study CD4-Positive T-Lymphocytes Human HIV Infections/DRUG THERAPY/*THERAPY Interferon-alpha/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ *THERAPEUTIC USE Leukocyte Count Opportunistic Infections/COMPLICATIONS Sarcoma, Kaposi's/ETIOLOGY Zidovudine/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/*THERAPEUTIC USE ABSTRACT 921230
M92C5333
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Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.
