Status:
COMPLETED
Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Hoffmann-La Roche
Gilead Sciences
Conditions:
Leukoencephalopathy, Progressive Multifocal
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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....
Detailed Description
The aim of this open-label multicentre study is to estimate the effect of an early therapy intensification based on potent antiretroviral combination including enfuvirtide(FUZEON®) on survival in pati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00120367
Start Date
April 1 2005
End Date
December 1 2007
Last Update
December 22 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service de Medecine interne et Maladies Infectieuses, Hopital Bicetre
Le Kremlin-Bicêtre, France, 94270