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NCT03969550 Clinical Trial

Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy?

AIDS Clinical Trial

Official title:
Do CCR5 Antagonists Improve the Overall Survival of Patients With AIDS-related Progressive Multifocal Leucoencephalopathy?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03969550
Other study ID # 29305436
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2008
Est. completion date December 2015

Study information
Verified date May 2019
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival (OS) 8 years
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