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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091932
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Zhejiang University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 20, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: PD-1 inhibitor




Primary Outcome Measures :
  1. the rate of non-progressors and recovers of AIDS patients with PML in 6 months after receiving PD-1 inhibitor [ Time Frame: 6 months ]
    With treatment of Pembrolizumab for 6 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML

  2. the rate of non-progressors and recovers of AIDS patients with PML in 12 months after receiving PD-1 inhibitor [ Time Frame: 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 :
  1. the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid,blood and urine in patients receiving Pembrolizumab. [ Time Frame: 3 months ]
    With treatment of Pembrolizumab for 3 months, we will evaluate the negative conversion rate of JCV in cerebrospinal fluid,blood and urine

  2. Side effects associated with Pembrolizumab [ Time Frame: 12 months ]
    To investigate the safety of Pembrolizumab in HIV patients

  3. The rate of patients with decreased HIV viral reservoir [ Time Frame: 12 months ]
    To investigate the rate of patients with decreased HIV viral reservoir



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091932


Contacts
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Contact: Biao Zhu, PhD 13906535457 zhubiao1207@zju.edu.cn
Contact: Junwei Su, MD 13777441318 1514031@zju.edu.cn

Locations
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China, Zhejiang
the first affiliated hospital of Zhejiang university school of medicine Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Junwei Su, MD    13777441318    zjusujunwei@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Investigators
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Principal Investigator: Biao Zhu, PhD Zhejiang University
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Responsible Party: First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT04091932    
Other Study ID Numbers: 2019-57
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital of Zhejiang University:
PD-1 inhibitor
Pembrolizumab
Progressive Multifocal Leukoencephalopathy
AIDS
Additional relevant MeSH terms:
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Leukoencephalopathy, Progressive Multifocal
Leukoencephalopathies
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
Polyomavirus Infections
DNA Virus Infections
Slow Virus Diseases
Infectious Encephalitis
Encephalitis
Central Nervous System Infections
Demyelinating Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents