Treatment of PD-1 Inhibitor in AIDS-associated PML (TPAP)

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: AIDS; Progressive Multifocal Leukoencephalopathy

Treatments: Drug: Pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04091932

2019-57

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pembrolizumab treatment

Experimental group

Description:

Pembrolizumab dosage form:100mg/4ml dosage:2mg/kg weight frequency: once per 4 weeks duration:12 weeks

Treatment:

Drug: Pembrolizumab