PHASE II STUDY OF INTERMITTENT RECOMBINANT HUMAN INTERLEUKIN 2 BY INTRAVENOUS

$0M01FY2000RRNIH

Ohio State University, Columbus OH

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Abstract

The recommended treatment of persons with HIV includes the use of triple therapy with antiviral agents in an attempt to suppress the level of HIV in the blood below the limits of detection. The combination of indinavir (a protease inhibitor)+ zidovudine (AZT) + lamivudine (3TC) has been shown to suppress the level of RNA and reduce the rate of clinical disease progression. The addition of delavirdine to indinavir results 2 to 5 times higher indinavir levels. In some patients failing combination anti-HIV therapy which included indinavir, the additions of delavirdine resulted in improvement in CD4 and viral load measures. The study will compare the indinavir pharmacokinetics, safety and tolerance and antiviral activity of the three arms.

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