Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy?
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Completed
CT.gov ID
NCT03969550
Collaborator
(none)
34
95
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
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
:
Jan 1, 2008
Actual Primary Completion Date
:
Dec 1, 2015
Actual Study Completion Date
:
Dec 1, 2015
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [8 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with AR-PML
-
Diagnosed between January 2008 and December 2015
-
Followed in one of the four University Hospitals' Infectious Diseases Departments
Exclusion Criteria:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT03969550
Other Study ID Numbers:
- 29305436
First Posted:
May 31, 2019
Last Update Posted:
May 31, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild
Additional relevant MeSH terms: