AEGiS-04CROI: ARA-C treatment of PML in AIDS patients.

4th Conference on Retroviruses and Opportunistic Infections

Washington, DC - January 22-26, 1997

ARA-C treatment of PML in AIDS patients.

Conf Retroviruses Opportunistic Infect 1997 Jan 22-26; 4th:66 (abstract no. 8)

Hall C, Timpone J, Dafni I, Antonijevic Z, Millar L, Booss J, Clifford D, Cohen B, McArthur J, Hollander H; UNC Chapel Hill, Chapel Hill, NC.

ACTG 243 was designed to evaluate the safety and efficacy of ARA-C in PML in HIV infected subjects.

Objectives: Primary 1) efficacy in preventing death, 2) safety of the three treatment arms. Secondary 2) safety and efficacy in preventing neurologic decline, 2) effects on Karnofsky score, 3) effects on MRI. Design: 90 patients randomized to one of three arms:- A- antiretroviral therapy alone; B- antiretroviral therapy plus intravenous ARA-C; C-antiretroviral therapy plus intrathecal ARA-C. Inclusion criteria: included brain biopsy with light microscopy and in-situ hybridization for JCV. Subjects were treated actively for 24 weeks, and were followed until death or closure of the study. GCSF salvage was permitted.

Results: Interim analysis was performed after 62 subjects had been randomized. Thirty six subjects had died from PML, two from HIV progression, one from PCP and one from unknown causes. No significant difference in deaths was seen when comparing the ARA-C treated arms with antiretrovirals alone. Two subjects discontinued therapy permanently because of treatment toxicity. Toxicities were marginally significantly higher in arm A. Conditional power calculations indicated no more than a 20% chance of reaching the null hypothesis even if all future data supported the alternative hypothesis. The investigators concluded that, based on these findings, ARA-C as administered in this study showed no efficacy in the treatment of PML. Study termination was recommended.

Keywords: AEGIS, Leukoencephalopathy, Progressive Multifocal, Cytarabine, Acquired Immunodeficiency Syndrome, Anti-HIV Agents, Reverse Transcriptase Inhibitors, HIV Infections, HIV, Drug Therapy, Combination, HIV Protease Inhibitors, HIV-1, Antimetabolites, Antineoplastic, HIV Core Protein p24, Human, therapy, drug therapy, AIDS

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Copyright © 1980, 1997 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed through AIDSLINE, National Library of Medicine.