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.

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Key information

Conditions

AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Communicable Diseases DNA Virus Infections Demyelinating Diseases Encephalitis Encephalitis, Viral Genital Diseases HIV Infections Immune Reconstitution Inflammatory Syndrome Immune System Diseases Immunologic Deficiency Syndromes Infections Infectious Encephalitis Lentivirus Infections Leukoencephalopathies Leukoencephalopathy, Progressive Multifocal Nervous System Diseases Neuroinflammatory Diseases Polyomavirus Infections Progressive Multifocal Leucoencephalopathy (PML) RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measure of overall survival

Other

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

Primary outcomes

Overall survival (OS)

Time frame: 8 years

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Important dates

Study start: 2008
Primary completion: 2015
Study completion: 2015
First posted: May 31, 2019
Registry last updated: May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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