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

Rodolphe Thiebaut, Ana Jarne, Jean Pierre Routy, Irini Sereti, Margaret Fischl, Prudence Ive, R. Speck, Gianpiero D'Offizi, Salvatore Casari, Daniel Commenges, Sharne Foulkes, Ven Natarajan, Therese Croughs, J. F. Delfraissy, Giuseppe Tambussi, Y. Levy, Michael Lederman

Research output: Contribution to journalArticle

Abstract

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 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.

Original languageEnglish
Pages (from-to)1178-1185
Number of pages8
JournalClinical Infectious Diseases
Volume62
Issue number9
DOIs
Publication statusPublished - May 1 2016

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Interleukin-7
Multicenter Studies
HIV
T-Lymphocytes
CD4 Lymphocyte Count
Subcutaneous Injections
Therapeutics
Random Allocation
South Africa
Canada
RNA

Keywords

  • CD4
  • HIV
  • immune restoration
  • Interleukin-7
  • T-cell recovery

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)

Cite this

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. / Thiebaut, Rodolphe; Jarne, Ana; Routy, Jean Pierre; Sereti, Irini; Fischl, Margaret; Ive, Prudence; Speck, R.; D'Offizi, Gianpiero; Casari, Salvatore; Commenges, Daniel; Foulkes, Sharne; Natarajan, Ven; Croughs, Therese; Delfraissy, J. F.; Tambussi, Giuseppe; Levy, Y.; Lederman, Michael.

In: Clinical Infectious Diseases, Vol. 62, No. 9, 01.05.2016, p. 1178-1185.

Research output: Contribution to journalArticle

Thiebaut, R, Jarne, A, Routy, JP, Sereti, I, Fischl, M, Ive, P, Speck, R, D'Offizi, G, Casari, S, Commenges, D, Foulkes, S, Natarajan, V, Croughs, T, Delfraissy, JF, Tambussi, G, Levy, Y & Lederman, M 2016, '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', Clinical Infectious Diseases, vol. 62, no. 9, pp. 1178-1185. https://doi.org/10.1093/cid/ciw065
Thiebaut, Rodolphe ; Jarne, Ana ; Routy, Jean Pierre ; Sereti, Irini ; Fischl, Margaret ; Ive, Prudence ; Speck, R. ; D'Offizi, Gianpiero ; Casari, Salvatore ; Commenges, Daniel ; Foulkes, Sharne ; Natarajan, Ven ; Croughs, Therese ; Delfraissy, J. F. ; Tambussi, Giuseppe ; Levy, Y. ; Lederman, Michael. / 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. In: Clinical Infectious Diseases. 2016 ; Vol. 62, No. 9. pp. 1178-1185.
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