Back to resultsTreatment of PD-1 Inhibitor in AIDS-associated PML (TPAP)
Primary Purpose
Progressive Multifocal Leukoencephalopathy, AIDS
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Progressive Multifocal Leukoencephalopathy focused on measuring PD-1 inhibitor, Pembrolizumab, Progressive Multifocal Leukoencephalopathy, AIDS
Eligibility Criteria
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
Sites / Locations
- the first affiliated hospital of Zhejiang university school of medicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pembrolizumab treatment
Arm Description
Pembrolizumab dosage form:100mg/4ml dosage:2mg/kg weight frequency: once per 4 weeks duration:12 weeks
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Side effects associated with Pembrolizumab
To investigate the safety of Pembrolizumab in HIV patients
The rate of patients with decreased HIV viral reservoir
To investigate the rate of patients with decreased HIV viral reservoir
Full Information
NCT ID
NCT04091932
First Posted
September 15, 2019
Last Updated
September 18, 2019
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04091932
Brief Title
Treatment of PD-1 Inhibitor in AIDS-associated PML
Acronym
TPAP
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Multifocal Leukoencephalopathy, AIDS
Keywords
PD-1 inhibitor, Pembrolizumab, Progressive Multifocal Leukoencephalopathy, AIDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab treatment
Arm Type
Experimental
Arm Description
Pembrolizumab dosage form:100mg/4ml dosage:2mg/kg weight frequency: once per 4 weeks duration:12 weeks
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
PD-1 inhibitor
Intervention Description
Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months.
Primary Outcome Measure Information:
Title
the rate of non-progressors and recovers of AIDS patients with PML in 6 months after receiving PD-1 inhibitor
Description
With treatment of Pembrolizumab for 6 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML
Time Frame
6 months
Title
the rate of non-progressors and recovers of AIDS patients with PML in 12 months after receiving PD-1 inhibitor
Description
With treatment of Pembrolizumab for 12 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid，blood and urine in patients receiving Pembrolizumab.
Description
With treatment of Pembrolizumab for 3 months, we will evaluate the negative conversion rate of JCV in cerebrospinal fluid，blood and urine
Time Frame
3 months
Title
Side effects associated with Pembrolizumab
Description
To investigate the safety of Pembrolizumab in HIV patients
Time Frame
12 months
Title
The rate of patients with decreased HIV viral reservoir
Description
To investigate the rate of patients with decreased HIV viral reservoir
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Biao Zhu, PhD
Phone
13906535457
Email
zhubiao1207@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Junwei Su, MD
Phone
13777441318
Email
1514031@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biao Zhu, PhD
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the first affiliated hospital of Zhejiang university school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junwei Su, MD
Phone
13777441318
Email
zjusujunwei@163.com
12. IPD Sharing Statement
Learn more about this trial
Treatment of PD-1 Inhibitor in AIDS-associated PML
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