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Repeated Cycles of Recombinant Human Interleukin 7 in HIV-Infected Patients With Low CD4 T-Cell Reconstitution on Antiretroviral Therapy: Results of 2 Phase II Multicenter Studies

2016; Oxford University Press; Volume: 62; Issue: 9 Linguagem: Inglês

10.1093/cid/ciw065

1537-6591

Rodolphe Thiébaut, Ana Jarné, Jean-Pierre Routy, Irini Sereti, Margaret A. Fischl, Prudence Ive, Roberto F. Speck, Gianpiero D’Offizi, Salvatore Casari, Daniel Commenges, Sharne Foulkes, Ven Natarajan, Thérèse Croughs, Jean-François Delfraissy, Giuseppe Tambussi, Yves Lévy, Michael M. Lederman,

Cytomegalovirus and herpesvirus research

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 >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 <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 63% of their follow-up time with a CD4 T-cell count >500 cells/µL. Conclusions. Repeated cycles of r-hIL-7 were well tolerated and achieved sustained CD4 T-cell restoration to >500 cells/µL in the majority of study participants. Clinical Trials Registration. INSPIRE II: clinicaltrials.gov (NCT01190111) and INSPIRE III: EudraCT (No. 2010-019773-15) and clinicaltrials.gov (NCT01241643).