Treatment of PD-1 Inhibitor in AIDS-associated PML

NCT ID: NCT04091932

Last Updated: 2019-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2021-12-31

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.

Conditions

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Progressive Multifocal Leukoencephalopathy AIDS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pembrolizumab treatment

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

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type DRUG

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

Interventions

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Pembrolizumab

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

Intervention Type DRUG

Other Intervention Names

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PD-1 inhibitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Biao Zhu, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

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the first affiliated hospital of Zhejiang university school of medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Biao Zhu, PhD

Role: CONTACT

13906535457

Junwei Su, MD

Role: CONTACT

13777441318

Facility Contacts

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Junwei Su, MD

Role: primary

13777441318

Other Identifiers

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2019-57

Identifier Type: -

Identifier Source: org_study_id

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