Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04091932
Other study ID # 2019-57
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06044792 - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Not yet recruiting NCT03661203 - Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM
Completed NCT02711878 - Healing Hearts and Mending Minds in Older Adults Living With HIV N/A
Completed NCT02606344 - Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV N/A
Completed NCT01348308 - Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients Phase 3
Completed NCT01053598 - Evaluation Of The Performance Of The Nitrate Reductase And Resazurin Titre Assay For The Detection of Mycobacterium Tuberculosis Complex From Sputum In A High Tb and Hiv Setting N/A
Completed NCT01237366 - Study Targeting Affect Regulation Phase 1/Phase 2
Withdrawn NCT00951795 - Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts N/A
Completed NCT00740389 - TMC125-TiDP2-C187: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Interaction Between TMC125 and Two Antifungal Agents (Fluconazole and Voriconazole), All at Steady-state in Healthy Subjects. Phase 1
Withdrawn NCT00347750 - Pharmacokinetics and Pharmacodynamics of an Anti-HIV Drug in Israeli Ethiopian and Non-Ethiopian Populations Phase 3
Completed NCT00317460 - Buprenorphine and Integrated HIV Care Phase 4
Withdrawn NCT00340223 - HLA-B35 Alleles and AIDS N/A
Completed NCT01084395 - Reducing HIV Risk Among Mexican Youth N/A
Completed NCT00144352 - In-Vivo Response of P. Falciparum to Antimalarial Treatment in HIV-Infected and HIV-Uninfected Adults Phase 4
Completed NCT00202241 - The Effects of Anabolic Steroids and Protease Inhibitors on People Living With HIV/AIDS N/A
Completed NCT00341172 - The Effects of Genetic Differences Among AIDS Patients on Cytomegalovirus Retinitis
Recruiting NCT06145841 - Metagenomic Next-Generation Sequencing Guides Anti-Infection Strategies
Completed NCT03633721 - Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women Phase 2
Completed NCT04567693 - Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV N/A
Completed NCT03023033 - Supporting Attendance for Facility Delivery and Infant Health N/A