Conditions: Progressive Multifocal Leukoencephalopathy
Keywords: PML Human Polyomavirus JC HIV Central Nervous System Disease Mefloquine JC Virus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: no

Brief summary:
The primary objective of the study was to explore whether mefloquine can delay or stop progression of progressive multifocal leukoencephalopathy (PML) as measured by JC virus (human polyomavirus or JCV) deoxyribonucleic acid (DNA) levels in cerebrospinal fluid (CSF). The secondary objective of the study was to explore whether mefloquine can delay or stop progression of PML based on neurological deterioration, magnetic resonance imaging (MRI) measures of brain lesion evolution or the formation of new lesions, and mortality.

Detailed description:

Arms:
arm 1: All participants received local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.

Participants in this treatment arm had the option of adding 250 mg mefloquine by mouth at Week 4 (Day 28) or Week 8 (Day 56) daily for 3 days, and then weekly through Week 24. arm 2: All participants received local standard of care, which may have included any treatment or procedure that the Investigator would normally use in the treatment of a PML patient at their study site or hospital.

Participants received 250 mg mefloquine by mouth on Days 0, 1, and 2 and then weekly through Week 24.

Interventions: intervention 1: mefloquine
Intervention descriptions: intervention 1: 250 mg orally each day for 3 days and then weekly up to 6 months.

Protocol document: