AIDS Clinical Trial
— TPAPOfficial 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
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | the first affiliated hospital of Zhejiang university school of medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University |
China,
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 |
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