HIV-infected patients with Progressive Multifocal Leukoencephalopathy MedDRA version: 15.0 Level: PT Classification code 10036807 Term: Progressive multifocal leukoencephalopathy System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Recombinant human interleukin-7
Product Code: CYT107
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: CYT107
Other descriptive n
Sponsors
Cytheris S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years. 2. HIV-1 infection. 3. Neurological findings compatible with the development of active PML, established by criteria defined in protocol 4. Patients have to be on effective cART after PML diagnosis, for at least 4 weeks. 5. HIV RNA load in blood =65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast feeding. 2. Refusal or inability to practice contraception regardless of the gender of the patient. 3. MRI documented PML-IRIS. 4. Prior treatment with interleukin-7. 5. Hepatitis B surface antigen (HBsAg) positive. 6. ALT and/or AST > 5 x ULN. 7. Use of another investigational or interventional treatment within the last 3 months prior to study entry. 8. Any current malignancy except Kaposi Sarcoma that does not require chemotherapy. 9. Current opportunistic CNS infection. 10. Active tuberculosis. 11. Other current severe illness or other conditions (such as autoimmune disease, severe mental illness) that, in the opinion of the investigator, would make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess CYT107 efficacy on JCV clearance from cerebrospinal fluid.;Secondary Objective: The secondary objectives of this study are: o to assess the clinical safety of CYT107 o to assess the effect on patient survival o to measure the effect on neurological and clinical status o to assess the biological activity of CYT107: - on the kinetics of JCV reduction in CSF - on the main parameters of the immune reconstitution - on the specific T-cell response against the JC virus ;Primary end point(s): The primary endpoint is defined as the clearance of the JCV from the CSF at M3.;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • Kinetics of the JC viral load changes • “Survival” curves for time to JCV viral clearance in CSF • MRI lesions changes • Percentage change in neurological scores • Change in Karnofsky Performance Status; • MRS scores • Proportion of patients with a MRS score < 3 • Changes in CD4+ and CD8+ T-cell subsets • Changes of specific T-cell responses, proliferation indices, JCV-specific T-cell responses • Survival rate ;Timepoint(s) of evaluation of this end point: Timepoints of evaluation of secondary endpoints are as follows: • Kinetics of the JCV viral load changes from D0 to M3 • Kinetics of the JCV viral load changes from D0 to M12 • “Survival” curves for time to JCV viral clearance in CSF • Percentage change in neurological scores between baseline and M12 • Change in Karnofsky Performance Status between D0 and M12; • MRS scores at M12 • Survival rate at M12 | — |
Countries
European Union, Italy, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactCytheris Information
Cytheris S.A.
Outcome results
None listed