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 |
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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 |
Keywords
- CD4
- HIV
- immune restoration
- Interleukin-7
- T-cell recovery
ASJC Scopus subject areas
- Infectious Diseases
- Microbiology (medical)