Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125)

NCT00120367 | Completed Phase 2

• 2 other identifiers: ANRS 1252005-000424-16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Progressive multifocal leucoencephalopathy (PML) is a rare infectious disease of the brain, provoked by the JC virus. It usually occurs in subjects with impaired immune system as during HIV infection. To date, there is no specific antiviral treatment susceptible to cure PML. But it was shown in the setting of HIV-related PML, that combination antiretroviral therapy allows a restoration of the immune system and then might stop the progression of PML. The objective of this study is to appreciate the supplementary efficiency brought by an association of more powerful antiretroviral molecules including enfuvirtide on the evolution of PML. This research program will involve 30 patients in several centres in France. All the patients who will participate will receive enfuvirtide during 6 months in association with a combination of two or more potent antiretroviral drugs. The total duration of follow-up for a patient will be of 1 year.

Conditions

Leukoencephalopathy, Progressive Multifocal; HIV Infections

Keywords

Leukoencephalopathy, Progressive Multifocal; HIV infections; HIV Fusion Inhibitors

Outcome Measures

Primary Outcomes (1)

• Estimation by the method of Kaplan-Meier of the rate of survival at M12

Secondary Outcomes (4)

• Rate of survival and functional score (Modified Rankin Outcome Scale) at M12

• Evolution of the JC viral load in the CSF and percentage of patients with JC virus clearance of the CSF to M3 and M6

• Evolution of the CD4 and CD8 T cells sub-populations and of the antivirus JC specific T cell responses at M12

• Dosage of the concentration of enfuvirtide in the CSF

Interventions

Enfuvirtide DRUG

Tenofovir-Emtricitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Have confirmed laboratory diagnosis of HIV infection
• Presenting with a clinical history of active PML evolving (or continuing to deteriorate) for less than 90 days
• Signed written inform consent

You may not qualify if:

• Concomitant opportunistic infection of the central nervous system
• Pregnancy, breast-feeding
• Co-infection by the HIV2
• History of immunotherapy including interleukin-2 and alpha-interferon
• History of treatment by FUZEON® or by cidofovir
• Contra-indication to receive FUZEON

Sponsors & Collaborators

• Hoffmann-La Roche: collaborator
• French National Agency for Research on AIDS and Viral Hepatitis: lead
• Gilead Sciences: collaborator

Study Sites (1)

Service de Medecine interne et Maladies Infectieuses, Hopital Bicetre

Le Kremlin-Bicêtre, 94270, France

Location

Related Publications (1)

• Gasnault J, Costagliola D, Hendel-Chavez H, Dulioust A, Pakianather S, Mazet AA, de Goer de Herve MG, Lancar R, Lascaux AS, Porte L, Delfraissy JF, Taoufik Y; ANRS 125 Trial Team. Improved survival of HIV-1-infected patients with progressive multifocal leukoencephalopathy receiving early 5-drug combination antiretroviral therapy. PLoS One. 2011;6(6):e20967. doi: 10.1371/journal.pone.0020967. Epub 2011 Jun 30.

  PMID: 21738597 DERIVED

MeSH Terms

Conditions

Leukoencephalopathy, Progressive Multifocal; HIV Infections

Interventions

Enfuvirtide

Condition Hierarchy (Ancestors)

Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Virus Diseases; Polyomavirus Infections; DNA Virus Infections; Slow Virus Diseases; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Leukoencephalopathies; Demyelinating Diseases; Neuroinflammatory Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; HIV Envelope Protein gp41; Viral Fusion Proteins; Membrane Fusion Proteins; Membrane Proteins; Proteins; HIV Antigens; Antigens, Viral; Viral Proteins; env Gene Products, Human Immunodeficiency Virus; Gene Products, env; Retroviridae Proteins; Human Immunodeficiency Virus Proteins; Viral Envelope Proteins; Viral Structural Proteins; Antigens; Biological Factors

Study Officials

• Jacques Gasnault, MD

  Hopital Bicetre Kremlin Bicetre France

  PRINCIPAL INVESTIGATOR

• Dominique Costagliola

  Inserm U720

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2005
• First Posted: July 18, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 2, 2026

Record last verified: 2011-12

Locations

FR (1)