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CompletedNCT03969550Updated May 31, 2019

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

An observational study in AIDS and Progressive Multifocal Leucoencephalopathy (PML), sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-31.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
34
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • AIDS
  • Progressive Multifocal Leucoencephalopathy (PML)

Keywords

  • Maraviroc
  • John Cunningham virus (JCV)
  • Immune reconstitution inflammatory syndrome (IRIS)
  • Combined antiretroviral treatment (cART)
  • Overall survival (OS)
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In context

Acquired Immunodeficiency Syndrome

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

This study's enrollment of 34 is below the median of 287 across 503 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
34 participants (actual)
Patient registry
No

Interventions

  • OtherMeasure 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.

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What researchers measure

Primary outcomes

  1. Overall survival (OS)

    Time frame: 8 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03969550
Responsible party
Sponsor
First posted
May 31, 2019
Start date
Jan 2008
Primary completion
Dec 2015
Completion
Dec 2015
Last update
May 31, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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