Journal
BLOOD
Volume 113, Issue 25, Pages 6304-6314Publisher
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2008-10-186601
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Funding
- National Institute of Allergy and Infectious Diseases
- Statistical and Data Analysis Center [AI 38855]
- AIDS Clinical Trials Units at Case Western Reserve University [AI 25879, AI 68636]
- Northwestern University [AI 25915]
- University of California, Davis Medical Center [AI 38858]
- University of Miami [AI 27675]
- National Institutes of Health
- Concerned Parents for AIDS Research
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Interleukin 7 (IL- 7) is a common gamma chain receptor cytokine implicated in thymopoiesis and in peripheral expansion and survival of T lymphocytes. The safety and activity of recombinant human IL- 7 (rhIL- 7) administration were therefore examined in HIV-infected persons. In this prospective randomized placebo-controlled study, a single subcutaneous dose of rhIL- 7 was well tolerated with biologic activity demonstrable at 3 mu g/kg and a maximum tolerated dose of 30 mu g/kg. Injection site reactions and transient elevations of liver function tests were the most notable side effects. Transient increases in plasma HIV-RNA levels were observed in 6 of 11 IL-7-treated patients. Recombinant hIL-7 induced CD4 and CD8 T cells to enter cell cycle; cell-cycle entry was also confirmed in antigen-specific CD8 T cells. Administration of rhIL-7 led to transient down-regulation of the IL-7 receptor alpha chain (CD127) in both CD4(+) and CD8(+) T cells. Single-dose rhIL-7 increased the numbers of circulating CD4(+) and CD8(+) T cells, predominantly of central memory phenotype. The frequency of CD4(+) T cells with a regulatory T-cell phenotype (CD25(high) CD127(low)) did not change after rhIL-7 administration. Thus, rhIL-7 has a biologic and toxicity profile suggesting a potential for therapeutic trials in HIV infection and other settings of lymphopenia. This clinical trial has been registered at http://www.clinicaltrials.gov under NCT0099671. (Blood. 2009; 113: 6304-6314)
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