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

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...

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Bibliographic Details
Published in:Clinical infectious diseases 2016-05, Vol.62 (9), p.1178-1185
Main Authors: Thiebaut, Rodolphe, jarne, Ana, Routy, Jean-Pierre, Sereti, Irini, Fischl, Margaret, lve, Prudence, Speck, Roberto F., D'Offizi, Gianpiero, Casari, Salvatore, Commenges, Daniel, Foulkes, Sharne, Natarajan, Ven, Croughs, Therese, Delfraissy, Jean-Francois, Tambussi, Guiseppe, Levy, Yves, Lederman, Michael M.
Format: Article
Language:English
Subjects:
Adult
Anti-HIV Agents - administration & dosage
Anti-HIV Agents - therapeutic use
CD4-Positive T-Lymphocytes - drug effects
CD4-Positive T-Lymphocytes - virology
Female
HIV - drug effects
HIV Infections - drug therapy
HIV/AIDS
Humans
Injections, Subcutaneous
Interleukin-7 - administration & dosage
Interleukin-7 - therapeutic use
Life Sciences
Male
Middle Aged
Recombinant Proteins - administration & dosage
Recombinant Proteins - therapeutic use
Santé publique et épidémiologie
Treatment Outcome
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Summary: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 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).
ISSN:1058-4838
1537-6591
DOI:10.1093/cid/ciw065