NCT04091932

Treatment of PD-1 Inhibitor in AIDS-associated PML

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Multifocal Leukoencephalopathy
• AIDS

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months.

Timeline

• Start date: 2019-08-20
• Primary completion: 2020-02-01
• Completion: 2021-12-01
• First posted: 2019-09-17
• Last updated: 2019-09-20

Locations

1 site across 1 country: China