Treatment of PD-1 Inhibitor in AIDS-associated PML

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect and Safety of Programmed Cell Death Protein 1 (PD-1) Inhibitor on AIDS Patients With Progressive Multifocal Leukoencephalopathy (PML): A One-center, Single-arm and Prospective Study

Conditions
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Progressive Multifocal Leukoencephalopathy, AIDS

Intervention / Treatment
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* Drug: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 Diagnosed of HIV by lab confirmation Diagnosed of PML by diplomatic radiologists through brain MRI or by brain biopsy once there are some concerns on radiologic diagnosis. agree to sign the consent agree to use contraception measures during 4 weeks before to 6 months after this study Exclusion Criteria: Pregnancy or lactating women or planing birth during this study Anticipated bad treatment compliance Within 6 months before joining this study, receive other immunosuppressors, immunomodulators or cytotoxic drugs (glucocorticoid is allowed)； 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pembrolizumab treatment<br>Pembrolizumab dosage form:100mg/4ml dosage:2mg/kg weight frequency: once per 4 weeks duration:12 weeks | Drug: Pembrolizumab<br>* Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months.<br>* Other names: PD-1 inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of non-progressors and recovers of AIDS patients with PML in 6 months after receiving PD-1 inhibitor | With treatment of Pembrolizumab for 6 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML | 6 months | 
| the rate of non-progressors and recovers of AIDS patients with PML in 12 months after receiving PD-1 inhibitor | With treatment of Pembrolizumab for 12 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid，blood and urine in patients receiving Pembrolizumab. | With treatment of Pembrolizumab for 3 months, we will evaluate the negative conversion rate of JCV in cerebrospinal fluid，blood and urine | 3 months | 
| Side effects associated with Pembrolizumab | To investigate the safety of Pembrolizumab in HIV patients | 12 months | 
| The rate of patients with decreased HIV viral reservoir | To investigate the rate of patients with decreased HIV viral reservoir | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-1 inhibitor, Pembrolizumab, Progressive Multifocal Leukoencephalopathy, AIDS