Progressive Multifocal LeukoencephalopathyPhase 2TPAPNCT04091932
Treatment of PD-1 Inhibitor in AIDS-associated PML
A Phase 2 study testing Pembrolizumab in people with Progressive Multifocal Leukoencephalopathy and AIDS, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Progressive Multifocal Leukoencephalopathy, AIDS
- What is being tested?
- Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2019to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65
- Diagnosed of HIV by lab confirmation
- Diagnosed of PML by diplomatic radiologists through brain MRI or by brain biopsy once there are some concerns on radiologic diagnosis.
- agree to sign the consent
- agree to use contraception measures during 4 weeks before to 6 months after this study
Who cannot join
- Pregnancy or lactating women or planing birth during this study
- Anticipated bad treatment compliance
- Within 6 months before joining this study, receive other immunosuppressors, immunomodulators or cytotoxic drugs (glucocorticoid is allowed)；
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Zhejiang university school of medicine
Hangzhou, Zhejiang, 310000
Junwei Su, MD, 13777441318, zjusujunwei@163.com
About this study
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
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.
Read the 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
- Being tested
- Pembrolizumab
- Keywords
- PD-1 inhibitor, Pembrolizumab, Progressive Multifocal Leukoencephalopathy, AIDS
- Medical subject headings
- Leukoencephalopathy, Progressive Multifocal, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called PD-1 inhibitor
Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab treatment | Experimental | Pembrolizumab dosage form:100mg/4ml dosage:2mg/kg weight frequency: once per 4 weeks duration:12 weeks Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Secondary outcomes (3)
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
Measured: 3 months
Side effects associated with Pembrolizumab
To investigate the safety of Pembrolizumab in HIV patients
Measured: 12 months
The rate of patients with decreased HIV viral reservoir
To investigate the rate of patients with decreased HIV viral reservoir
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start20 Aug 2019
- Primary completionFeb 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multifocal LeukoencephalopathyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Biao Zhu, PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091932
- Sponsor's protocol ID
- 2019-57
- Acronym
- TPAP
- Status last verified
- Aug 2019
- First submitted
- 15 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04091932
- Acronym / sponsor ID
- TPAP / 2019-57
- Conditions
- Progressive Multifocal Leukoencephalopathy, AIDS
- Keywords
- PD-1 inhibitor, Pembrolizumab, Progressive Multifocal Leukoencephalopathy, AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab treatment | Experimental | Drug: PembrolizumabPembrolizumab dosage form:100mg/4ml dosage:2mg/kg weight frequency: once per 4 weeks duration:12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-65
- Diagnosed of HIV by lab confirmation
- Diagnosed of PML by diplomatic radiologists through brain MRI or by brain biopsy once there are some concerns on radiologic diagnosis.
- agree to sign the consent
- agree to use contraception measures during 4 weeks before to 6 months after this study
Key exclusion criteria (5 listed)
- Pregnancy or lactating women or planing birth during this study
- Anticipated bad treatment compliance
- Within 6 months before joining this study, receive other immunosuppressors, immunomodulators or cytotoxic drugs (glucocorticoid is allowed)；
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: PD-1 inhibitorMonthly usage of Pembrolizumab (2mg/kg weight) for 3 months. | Drug | Pembrolizumab treatment |
Primary outcome
the rate of non-progressors and recovers of AIDS patients with PML in 6 months after receiving PD-1 inhibitor
Time frame: 6 months
With treatment of Pembrolizumab for 6 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML
the rate of non-progressors and recovers of AIDS patients with PML in 12 months after receiving PD-1 inhibitor
Time frame: 12 months
With treatment of Pembrolizumab for 12 months, we will evaluate the rate of non-progressors and recovers of AIDS patients with PML
3 secondary outcomes
the negative conversion rate of John Cunningham virus (JCV) in cerebrospinal fluid，blood and urine in patients receiving Pembrolizumab.
Time frame: 3 months
Side effects associated with Pembrolizumab
Time frame: 12 months
The rate of patients with decreased HIV viral reservoir
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biao Zhu, PhD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Progressive Multifocal Leukoencephalopathy and AIDS, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biao Zhu, PhD (13906535457, zhubiao1207@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of non-progressors and recovers of AIDS patients with PML in 6 months after receiving PD-1 inhibitor (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.