ACTG 334:CYCLOSPORIN IN IMMUNE ACTIVATION &HIV EXPRESSION IN EARLY HIV

$21,006M01FY2000RRNIH

New York University School Of Medicine, New York NY

Investigators

Linked publications & trials

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Abstract

This is a Phase II study designed to determine the safety and activity of cyclosporin (CsA) over a twelve week period with a four week follow-up. The patient population will consist of early HIV disease (>500 CD4 cells) and will include a placebo arm. The primary objective will be to examine the effects of CsA on immune activation as monitored by plasma levels of soluble IL-2 receptors. The secondary objectives are to examine the effects of CsA on co-expression of CD25, CD38, and HLADR on CD8 and CD4 positive T cells, plasma HIV-1 RNA, serum beta-2 microglobulin and serum neopterin, and functional assays of immunity. The safety of low dose CsA will also be assessed.

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