Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 5:29 AM
Study NCT ID:
NCT04091932
Status:
UNKNOWN
Last Update Posted:
2019-09-20
First Post:
2019-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of PD-1 Inhibitor in AIDS-associated PML
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TPAP
Brief Summary:
PD-1 inhibitor ļ¼Pembrolizumab, 2mg/kg weight, once per 4 weeks and 3 times of medication usageļ¼treatment 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: