免费获得国外相关药品，最快 1 个工作日回馈药物信息
Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy?
Progressive multifocal leucoencephalopathy (PML) is a demyelinating disease caused by John Cunningham virus (JCV) reactivation. Numerous molecules have been overstated because there were inaccurately tested in non-rigorous clinical trial.
The objective is to draw lessons from repeatedly false hopes of unconfirmed PML treatments that might contribute to prescribing ineffective drugs on claimed efficacy in case reports or small series and by failing to respect the need for clinical trial evaluation before authorizing their widespread use.
| Condition or disease | Intervention/treatment |
|---|---|
| AIDS Progressive Multifocal Leucoencephalopathy (PML) | Other: Measure of overall survival |
| Study Type : | Observational |
| Actual Enrollment : | 34 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy? |
| Actual Study Start Date : | January 2008 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | December 2015 |
- Overall survival (OS) [ Time Frame: 8 years ]
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 29, 2019 | ||||
| First Posted Date | May 31, 2019 | ||||
| Last Update Posted Date | May 31, 2019 | ||||
| Actual Study Start Date | January 2008 | ||||
| Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Overall survival (OS) [ Time Frame: 8 years ] | ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy? | ||||
| Official Title | Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy? | ||||
| Brief Summary |
Progressive multifocal leucoencephalopathy (PML) is a demyelinating disease caused by John Cunningham virus (JCV) reactivation. Numerous molecules have been overstated because there were inaccurately tested in non-rigorous clinical trial. The objective is to draw lessons from repeatedly false hopes of unconfirmed PML treatments that might contribute to prescribing ineffective drugs on claimed efficacy in case reports or small series and by failing to respect the need for clinical trial evaluation before authorizing their widespread use. |
||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with AR-PML, exposed or not to maraviroc, as part of combined antiretroviral treatment (cART). | ||||
| Condition |
|
||||
| Intervention | Other: Measure of overall survival
Measure of overall survival among AR-PML (AIDS-related PML) patients, exposed or not to maraviroc (MVC), and immune reconstitution inflammatory syndrome (IRIS) onset.
|
||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
34 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | December 2015 | ||||
| Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: |
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03969550 | ||||
| Other Study ID Numbers | 29305436 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Fondation Ophtalmologique Adolphe de Rothschild | ||||
| Study Sponsor | Fondation Ophtalmologique Adolphe de Rothschild | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Fondation Ophtalmologique Adolphe de Rothschild | ||||
| Verification Date | May 2019 | ||||
