PMID: 11917239Mar 28, 2002Paper

Placebo-controlled trial of cyclosporin-A in HIV-1 disease: implications for solid organ transplantation

Journal of Acquired Immune Deficiency Syndromes : JAIDS
L H CalabreseAIDS Clinical Trials Group 334 Investigators

Abstract

Earlier open-label clinical trials have provided conflicting data on the effects of cyclosporin-A (CsA) on the clinical course and immune status of patients with HIV disease. With the prospects for wider use of CsA in the setting of solid organ transplantation in HIV-infected persons, data on the safety and immunologic activity of this agent are needed. We report here the results of a randomized, double-blind, placebo-controlled trial to assess the safety and immunologic activity of CsA administration in early HIV disease. Twenty-eight patients with confirmed HIV infection, CD4 cell counts greater than 500 x 106/L, and plasma HIV RNA >600 copies/mL were randomized to receive 2 mg/kg of CsA (Neoral) twice daily or identical placebo for 12 weeks. Subjects were stratified for the presence or absence of stable concomitant antiviral therapy. The primary end point was the effect of therapy on immune activation as assessed by the levels of soluble interleukin-2 receptors. Secondary end points included safety and effects of treatment on plasma HIV RNA, CD4 cell count, and other markers of immune activation and function. The low dose of CsA used in this study did not suppress immune activation or increase circulating CD4 cell counts. De...Continue Reading

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