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ESPRITEvaluation of Subcutaneous Proleukin in a Randomized International Trial. An international, multicentre, phase-3 clinical trial which examined whether adding Proleukin (a recombinant IL2) to combination antiretroviral therapy in adults with HIV infection would reduce the risk of AIDS-associated opportunistic diseases or death more effectively than combination antiretroviral therapy alone.
While the CD4+ T-cell counts (a surrogate marker of of participants who received IL2) rose an average of 160 cells/mm3 higher than those of participants in the control group—a statistically significant difference—the elevation did not offer any health advantage to HIV-infected individuals; indeed, the IL2 group had significantly more “grade-4” health events than did those who did not receive IL2.
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