CLI-107-15 Multicenter Phase IIb study of CYT107 in HIV-PML V2.0

• Research type

  Research Study

• Full title

  A randomized, placebo controlled, multicenter phase IIb study of human recombinant Interleukin-7 (CYT107) in HIV infected patients with Progressive Multifocal Leukoencephalopathy

• IRAS ID

  112770

• Contact name

  Alan Winston

• Sponsor organisation

  Cytheris S.A

• Eudract number

  2012-000725-41

• Research summary

  In the setting of HIV infection and despite combination antiretroviral therapy (cART), progressive multifocal leukoencephalopathy (PML) is still a devastating disease of the central nervous system leading to death or severe disability in survivors because no specific antiviral agent has shown significant clinical efficacy against JC virus, the causive agent of PML. This poor outcome is probably related to the time required to achieve an efficient anti-JCV immune reconstitution on cART. CYT107 (r-hIL-7) has demonstrated its capacity to induce a rapid immune reconstitution by increasing T cell populations CD4 and CD8 in several lymphopenic conditions, including HIV infection. The objective of this study is to demonstrate the safety and efficacy of CYT107 in HIV-related PML. CYT107 will be administered as three subcutaneous administrations at 20 æg/kg/week (one cycle). Methodology Phase IIb, randomized, placebo controlled, single-blind study with a balanced randomization with a 2/1 ratio (CYT107/Placebo) aiming at comparing the two arms for efficacy on the primary endpoint. Treatment Group: CYT107 Dose: 20 æg/kg/week. (5 æL/kg/week) Control Group: NaCl Dose: 5 æL/kg/week A total of 57 patients will be included in the study. Primary objective: to assess the CYT107 efficacy on JCV clearance from cerebrospinaflud (CSF) at Month 3. Main Secondary objectives: to assess the clinical safety of CYT107, the effects on patient survival, and on neurological and clinical status and to assess the biological activity of CYT107 The primary endpoint will be evaluated at Month 3 and patients will be followed for 12 months.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0866

• Date of REC Opinion

  22 Jan 2013

• REC opinion

  Further Information Favourable Opinion