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

StatusCompleted
PhasePhase 2
Started
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Record History

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  1. 2 versions Re-verified since Dec 21, 2011, no change to tracked fieldsv8-v9
  2. Study title expanded, about 1 wordv7
  3. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates: Dec 2007
    v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  5. 2 versions Re-verified since Jan 16, 2006, no change to tracked fieldsv3-v4
  6. Study Identification, Study Statusv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00120367
Lead Sponsor French National Agency for Research on AIDS and Viral Hepatitis
Collaborators: Hoffmann-La Roche, Gilead Sciences
Conditions
(from sponsor)		 Leukoencephalopathy, Progressive Multifocal, HIV Infections
Related terms HIV Infections, Leukoencephalopathy, Progressive Multifocal
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov