AIDS, Progressive Multifocal Leukoencephalopathy
Conditions
Keywords
PD-1 inhibitor, Pembrolizumab, Progressive Multifocal Leukoencephalopathy, AIDS
Brief summary
PD-1 inhibitor （Pembrolizumab, 2mg/kg weight, once per 4 weeks and 3 times of medication usage）treatment on AIDS patients with progressive multifocal leukoencephalopathy.
Detailed description
This is a one-center, single-arm and prospective study, planing recruiting 10 AIDS-associated PML patients. All patients will receive PD-1 inhibitor (Pembrolizumab) for 12 weeks, and the dose for each time is 2 mg per kg/weight, and the frequency is once per 4 weeks. The effect and safety of Pembrolizumab on AIDS-associated PML will be evaluated.
Interventions
DRUGPembrolizumab
Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months.
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-65 2. Diagnosed of HIV by lab confirmation 3. Diagnosed of PML by diplomatic radiologists through brain MRI or by brain biopsy once there are some concerns on radiologic diagnosis. 4. agree to sign the consent 5. agree to use contraception measures during 4 weeks before to 6 months after this study
Exclusion criteria
1. Pregnancy or lactating women or planing birth during this study 2. Anticipated bad treatment compliance 3. Within 6 months before joining this study, receive other immunosuppressors, immunomodulators or cytotoxic drugs (glucocorticoid is allowed)； 4. With neutrophil\<1000/mm3 or platelet\<75000/mm3 or allergic to PD-1 inhibitor 5）With severe basic diseases in heart, brain, lung, liver, kidney 6\) disagree to sign the consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of non-progressors and recovers of AIDS patients with PML in 6 months after receiving PD-1 inhibitor | 6 months | With treatment of Pembrolizumab for 6 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML |
| the rate of non-progressors and recovers of AIDS patients with PML in 12 months after receiving PD-1 inhibitor | 12 months | With treatment of Pembrolizumab for 12 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid，blood and urine in patients receiving Pembrolizumab. | 3 months | With treatment of Pembrolizumab for 3 months, we will evaluate the negative conversion rate of JCV in cerebrospinal fluid，blood and urine |
| Side effects associated with Pembrolizumab | 12 months | To investigate the safety of Pembrolizumab in HIV patients |
| The rate of patients with decreased HIV viral reservoir | 12 months | To investigate the rate of patients with decreased HIV viral reservoir |
Countries
China
Contacts
Primary ContactBiao Zhu, PhD
Backup ContactJunwei Su, MD
Outcome results
None listed