NCT04091932

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 20, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

September 15, 2019

Last Update Submit

September 18, 2019

Conditions

Progressive Multifocal LeukoencephalopathyAIDS

Keywords

PD-1 inhibitorPembrolizumabProgressive Multifocal LeukoencephalopathyAIDS

Outcome Measures

Primary Outcomes (2)

  • 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

    6 months

  • 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

    12 months

Secondary Outcomes (3)

  • the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid，blood and urine in patients receiving Pembrolizumab.

    3 months

  • Side effects associated with Pembrolizumab

    12 months

  • The rate of patients with decreased HIV viral reservoir

    12 months

Study Arms (1)

Pembrolizumab treatment

EXPERIMENTAL

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

Drug: Pembrolizumab

Interventions

PembrolizumabDRUG

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

Also known as: PD-1 inhibitor
Pembrolizumab treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • \) disagree to sign the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital of Zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Leukoencephalopathy, Progressive MultifocalAcquired Immunodeficiency Syndrome

Interventions

pembrolizumabImmune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Encephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisVirus DiseasesPolyomavirus InfectionsDNA Virus InfectionsSlow Virus DiseasesEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLeukoencephalopathiesDemyelinating DiseasesNeuroinflammatory DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic Uses

Study Officials

  • Biao Zhu, PhD

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Biao Zhu, PhD

CONTACT

13906535457zhubiao1207@zju.edu.cn

Junwei Su, MD

CONTACT

137774413181514031@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 17, 2019

Study Start

August 20, 2019

Primary Completion

February 1, 2020

Study Completion

December 1, 2021

Last Updated

September 20, 2019

Record last verified: 2019-08

Locations

CN(1)