The purpose of this project was to determine the efficacy of Ara-C comparing intravenous administration to intrathecal administration in the treatment of PML along with a comparison arm receiving maximized antiretroviral therapy alone. We only had one patient active in this clinical trial during the above time period. This patient was receiving intrathecal Ara-C. The patient tolerated the study treatment well. Despite this, the PML continued to progress and the patient discontinued the study at week 6 due to the PML progression. He died ten days later due to PML progression. The previous five patients all died as well due to PML progression and none survived a sufficient length of time to complete the trial (24 weeks). We recruited 6 patients total at Hopkins for this trial. Nationwide, there were 62 patients enrolled in the study. The Protocol Safety Monitoring Board (PSMB) for the Neurological AIDS Research Consortium met on 7/2/96 to review the results of this trial. No statistical differences were noted in the survival times between the three treatment arms nor in the two Ara-C arms combined (IV plus intrathecal) vs non Ara-C. The PSMB determined that there was only a very slight chance of showing a benefit of Ara-C treatment and recommended not enrolling additional subjects as the Ara-C treatment had not been found to be effective in treating PML. The original recruitment goal was 90 subjects. There were no major safety issues regarding the use of the study medication. The Ara-C was well tolerated by the study subjects.
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