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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: Gilead Sciences; Hoffmann-La Roche
• Treatments: Emtricitabine; Enfuvirtide; Tenofovir

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