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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00120367
• Date of registration: 11/07/2005
• Prospective Registration: No
• Primary sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Public title: Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125)
• Scientific title: Early Intensification of Combination Antiretroviral Therapy Including FUZEON® in the Treatment of Progressive Multifocal Leucoencephalopathy During HIV-1 Infection ANRS 125 Trial
• Date of first enrolment: April 2005
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00120367
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Dominique Costagliola
• Affiliation: Inserm U720

• Name: Jacques Gasnault, MD
• Affiliation: Hopital Bicetre Kremlin Bicetre France

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 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

- Diagnosis of PML documented for less than 30 days at the inclusion by cerebral
imaging (MRI) AND the absence of another demonstrated etiology AND the detection of
JCV DNA in the CSF by qualitative PCR.

- Signed written inform consent

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Leukoencephalopathy, Progressive Multifocal

Intervention(s)

Drug: Enfuvirtide

Drug: Tenofovir-Emtricitabine

Primary Outcome(s)

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

Secondary Outcome(s)

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

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

Dosage of the concentration of enfuvirtide in the CSF

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

Secondary ID(s)

2005-000424-16

ANRS 125

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche

Gilead Sciences