New hope for HIV patients with rare brain disease?
NCT ID NCT00120367
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding a powerful HIV drug called FUZEON® to standard antiretroviral therapy could help people with HIV who also have a rare brain infection called PML. PML is caused by a virus that attacks the brain when the immune system is weak. The goal was to see if the stronger drug combination could stop the infection from getting worse. The study included 30 adults in France and followed them for one year.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
- Start date
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Apr 2005
- Finished
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Dec 2007
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Service de Medecine interne et Maladies Infectieuses, Hopital Bicetre
Le Kremlin-Bicêtre, 94270, France
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