Status:
UNKNOWN
Treatment of PD-1 Inhibitor in AIDS-associated PML
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Progressive Multifocal Leukoencephalopathy
AIDS
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04091932
Start Date
August 20 2019
End Date
December 1 2021
Last Update
September 20 2019
Active Locations (1)
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1
the first affiliated hospital of Zhejiang university school of medicine
Hangzhou, Zhejiang, China, 310000