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                <title level="j">Clinical Infectious Diseases</title>
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                <term xml:lang="en">CD4</term>
                <term xml:lang="en">HIV</term>
                <term xml:lang="en">T-cell recovery</term>
                <term xml:lang="en">immune restoration</term>
                <term xml:lang="en">interleukin-7</term>
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              <p>Background: Phase I/II studies in human immunodeficiency virus (HIV)-infected patients receiving antiretroviral therapy have shown that a single cycle of 3 weekly subcutaneous (s/c) injections of recombinant human interleukin 7 (r-hIL-7) is safe and improves immune CD4 T-cell restoration. Herein, we report data from 2 phase II trials evaluating the effect of repeated cycles of r-hIL-7 (20 µg/kg) with the objective of restoring a sustained CD4 T-cell count &gt;500 cells/µL.Methods: INSPIRE 2 was a single-arm trial conducted in the United States and Canada. INSPIRE 3 was a 2 arm trial with 3:1 randomization to r-hIL-7 versus control conducted in Europe and South Africa. Participants with plasma HIV RNA levels &lt;50 copies/mL during antiretroviral therapy and with CD4 T-cell counts between 101 and 400 cells/µL were eligible. A repeat cycle was administered when CD4 T-cell counts fell to &lt;550 cells/µL.Results: A total of 107 patients were treated and received 1 (n = 107), 2 (n = 74), 3 (n = 14), or 4 (n = 1) r-hIL-7 cycles during a median follow-up of 23 months. r-hIL-7 was well tolerated. Four grade 4 events were observed, including 1 case of asymptomatic alanine aminotransferase elevation. After the second cycle, anti-r-hIL-7 binding antibodies developed in 82% and 77% of patients in INSPIRE 2 and 3, respectively (neutralizing antibodies in 38% and 37%), without impact on the CD4 T-cell response. Half of the patients spent &gt;63% of their follow-up time with a CD4 T-cell count &gt;500 cells/µL.Conclusions: Repeated cycles of r-hIL-7 were well tolerated and achieved sustained CD4 T-cell restoration to &gt;500 cells/µL in the majority of study participants.</p>
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