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Not all HIV-infected patients normalize their CD4-cell counts despite effective virologic control. Interleukin (IL)-7 is known to boost CD4-cell counts, but its efficacy, safety, and optimal dosing have not been established.
In a company-sponsored, placebo-controlled study, 26 patients on antiretroviral therapy who had viral loads <50 copies/mL and CD4 counts between 101 and 400 cells/mm3 were treated with recombinant human IL-7 (rhIL-7) once weekly for 3 weeks in escalating doses (10, 20, and 30 μg/kg).
Dose-dependent CD4-count increases were observed at 12 weeks (average increase, 323 cells/mm3) and sustained for up to 1 year. The increases were predominantly due to expansion of naive and central memory T cells rather than regulatory or act…