Treatment of PD-1 Inhibitor in AIDS-associated PML

AIDS Clinical Trial

— TPAP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04091932
• Other study ID #: 2019-57
• Status: Recruiting
• Phase: Phase 2
• Start date: August 20, 2019
• Est. completion date: December 2021

Study information

• Verified date: August 2019
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Biao Zhu, PhD
• Phone: 13906535457
• Email: zhubiao1207[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2021
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• Leukoencephalopathies
• Leukoencephalopathy, Progressive Multifocal
• Progressive Multifocal Leukoencephalopathy

Intervention

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

Locations

Country	Name	City	State
China	the first affiliated hospital of Zhejiang university school of medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid,blood and urine in patients receiving Pembrolizumab.	With treatment of Pembrolizumab for 3 months, we will evaluate the negative conversion rate of JCV in cerebrospinal fluid,blood and urine	3 months
Secondary	Side effects associated with Pembrolizumab	To investigate the safety of Pembrolizumab in HIV patients	12 months
Secondary	The rate of patients with decreased HIV viral reservoir	To investigate the rate of patients with decreased HIV viral reservoir	12 months