TPAP: Treatment of PD-1 Inhibitor in AIDS-associated PML

Sponsor

First Affiliated Hospital of Zhejiang University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04091932

Collaborator

(none)

Enrollment

Location

Arm

27.4

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Progressive Multifocal Leukoencephalopathy AIDS	Drug: Pembrolizumab	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 20, 2019

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pembrolizumab treatment Pembrolizumab dosage form:100mg/4ml dosage:2mg/kg weight frequency: once per 4 weeks duration:12 weeks	Drug: Pembrolizumab Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months. Other Names: PD-1 inhibitor

Arm

Intervention/Treatment

Experimental: Pembrolizumab treatment

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

Drug: Pembrolizumab

Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months.

Other Names:

PD-1 inhibitor

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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