UnknownPhase 2

Treatment of PD-1 Inhibitor in AIDS-associated PML

China10 participantsStarted 2019-08-20

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

the rate of non-progressors and recovers of AIDS patients with PML in 6 months after receiving PD-1 inhibitor

Timeframe: 6 months

the rate of non-progressors and recovers of AIDS patients with PML in 12 months after receiving PD-1 inhibitor

Timeframe: 12 months

Trial details

NCT IDNCT04091932

SponsorFirst Affiliated Hospital of Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02

Contact for this trial

Biao Zhu, PhD

13906535457 zhubiao1207@zju.edu.cn

View on ClinicalTrials.gov More Progressive Multifocal Leukoencephalopathy trials