NCT03969550

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

7.9 years

First QC Date

May 29, 2019

Last Update Submit

May 29, 2019

Conditions

AIDSProgressive Multifocal Leucoencephalopathy (PML)

Keywords

MaravirocJohn Cunningham virus (JCV)Immune reconstitution inflammatory syndrome (IRIS)Combined antiretroviral treatment (cART)Overall survival (OS)

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    8 years

Interventions

Measure of overall survivalOTHER

Measure of overall survival among AR-PML (AIDS-related PML) patients, exposed or not to maraviroc (MVC), and immune reconstitution inflammatory syndrome (IRIS) onset.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with AR-PML, exposed or not to maraviroc, as part of combined antiretroviral treatment (cART).

You may qualify if:

  • Patients with AR-PML
  • Diagnosed between January 2008 and December 2015
  • Followed in one of the four University Hospitals' Infectious Diseases Departments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeLeukoencephalopathy, Progressive MultifocalImmune Reconstitution Inflammatory Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectious EncephalitisPolyomavirus InfectionsDNA Virus InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLeukoencephalopathiesDemyelinating DiseasesNeuroinflammatory Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

January 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 31, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share