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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab treatment | Experimental | Pembrolizumab dosage form:100mg/4ml dosage:2mg/kg weight frequency: once per 4 weeks duration:12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Side effects associated with Pembrolizumab |
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Inclusion Criteria:
Exclusion Criteria:
6) disagree to sign the consent
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biao Zhu, PhD | Contact | 13906535457 | zhubiao1207@zju.edu.cn | |
| Junwei Su, MD | Contact | 13777441318 | 1514031@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Biao Zhu, PhD | Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hospital of Zhejiang university school of medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D007968 | Leukoencephalopathy, Progressive Multifocal |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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To investigate the safety of Pembrolizumab in HIV patients |
| 12 months |
| The rate of patients with decreased HIV viral reservoir | To investigate the rate of patients with decreased HIV viral reservoir | 12 months |
| D000069544 | Infectious Encephalitis |
| D014777 | Virus Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D012897 | Slow Virus Diseases |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D056784 | Leukoencephalopathies |
| D003711 | Demyelinating Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |