Treatment of PD-1 Inhibitor in AIDS-associated PML

Last updated: September 18, 2019
Sponsor: First Affiliated Hospital of Zhejiang University
Overall Status: Active - Recruiting

Phase

2

Condition

Hiv

Progressive Multifocal Leukoencephalopathy (Pml)

Treatment

N/A

Clinical Study ID

NCT04091932
2019-57
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 oncethere 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

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）Withsevere basic diseases in heart, brain, lung, liver, kidney

  1. disagree to sign the consent

Study Design

Total Participants: 10
Study Start date:
August 20, 2019
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • the first affiliated hospital of Zhejiang university school of medicine

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.