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 language | English |
|---|---|
| Pages (from-to) | 1178-1185 |
| Number of pages | 8 |
| Journal | Clinical Infectious Diseases |
| Volume | 62 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - May 1 2016 |
Fingerprint
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, Roberto F.; D'Offizi, Gianpiero; Casari, Salvatore; Commenges, Daniel; Foulkes, Sharne; Natarajan, Ven; Croughs, Therèse; Delfraissy, Jean François; Tambussi, Guiseppe; Levy, Yves; Lederman, Michael M.
In: Clinical Infectious Diseases, Vol. 62, No. 9, 01.05.2016, p. 1178-1185.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Repeated Cycles of Recombinant Human Interleukin 7 in HIV-Infected Patients with Low CD4 T-Cell Reconstitution on Antiretroviral Therapy
T2 - Results of 2 Phase II Multicenter Studies
AU - Thiebaut, Rodolphe
AU - Jarne, Ana
AU - Routy, Jean Pierre
AU - Sereti, Irini
AU - Fischl, Margaret
AU - Ive, Prudence
AU - Speck, Roberto F.
AU - D'Offizi, Gianpiero
AU - Casari, Salvatore
AU - Commenges, Daniel
AU - Foulkes, Sharne
AU - Natarajan, Ven
AU - Croughs, Therèse
AU - Delfraissy, Jean François
AU - Tambussi, Guiseppe
AU - Levy, Yves
AU - Lederman, Michael M.
PY - 2016/5/1
Y1 - 2016/5/1
N2 - 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.
AB - 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.
KW - CD4
KW - HIV
KW - immune restoration
KW - Interleukin-7
KW - T-cell recovery
UR - http://www.scopus.com/inward/record.url?scp=84966539095&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84966539095&partnerID=8YFLogxK
U2 - 10.1093/cid/ciw065
DO - 10.1093/cid/ciw065
M3 - Article
AN - SCOPUS:84966539095
VL - 62
SP - 1178
EP - 1185
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 9
ER -