Treatment of PD-1 Inhibitor in AIDS-associated PML

Phase 2

• Conditions: Progressive Multifocal Leukoencephalopathy; AIDS
• Interventions: Drug: Pembrolizumab

• Registration Number: NCT04091932
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2019-08
• Study Start: 2019-08-20
• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2019-09-15
• Study First Posted: 2019-09-17
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20
• Primary Completion: 2020-02
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Name	Time	Method
The rate of patients with decreased HIV viral reservoir	12 months	To investigate the rate of patients with decreased HIV viral reservoir
the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid，blood and urine in patients receiving Pembrolizumab.	3 months	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	12 months	To investigate the safety of Pembrolizumab in HIV patients

Trial Locations

Locations (1)

the first affiliated hospital of Zhejiang university school of medicine; 🇨🇳 Hangzhou, Zhejiang, China