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NEUROLOGY 2008;71:521-524
© 2008 American Academy of Neurology

Failure of atorvastatin to modulate CSF HIV-1 infection

Results of a pilot study

J. C. Probasco, BS, S. S. Spudich, MD, J. Critchfield, MD, E. Lee, BA, N. Lollo, BA, S. G. Deeks, MD and R. W. Price, MD

From the Departments of Neurology (J.C.P., S.S.S., E.L., N.L., R.W.P.) and Medicine (J.C., S.G.D.), University of California San Francisco.

Address correspondence and reprint requests to Dr. Richard W. Price, Neurology Service, Rm 4M62, San Francisco General Hospital (SFGH), 1001 Potrero Avenue, San Francisco, CA 94117 rwprice{at}sfgh.ucsf.edu

Background: HIV-1 infection of the CSF space is nearly universal in untreated systemic infection, and correlates strongly with intrathecal and systemic immunoactivation and CSF pleocytosis. Based on the potential immunomodulatory and antiviral properties of HMG-CoA reductase inhibitors (statins), we examined the effect of atorvastatin on CSF HIV-1 infection and associated CSF abnormalities in a small pilot study.

Methods: Seven male HIV-1-infected, antiretroviral-naïve subjects with a mean blood CD4+ T cell count of 473 cells/µL were studied in an open-label, single-arm pilot study to assess the effects of 80 mg atorvastatin daily for 8 weeks. The primary endpoint was the change in CSF HIV-1 RNA levels, both absolutely and relative to plasma HIV-1 RNA, at 4 and 8 weeks of treatment. Other outcome measures included CSF white blood cell counts and neopterin concentrations as indices of intrathecal immunoactivation, and blood HIV-1 RNA levels, neopterin concentrations, and T lymphocyte counts. Effects on blood lipids were used to monitor the established biologic effects of atorvastatin and treatment adherence.

Results: No significant changes in CSF virologic and inflammatory indices or in systemic HIV-1 infection were observed during atorvastatin treatment despite potent reduction of blood lipids.

Conclusion: Atorvastatin showed no appreciable effect on CSF HIV-1 infection or intrathecal immunoactivation in this small uncontrolled study and thus appears to have little promise as an immunomodulatory adjuvant therapy for CNS HIV-1 infection, at least in neuroasymptomatic subjects with preserved CD4+ T cell counts.

Abbreviations: ADC = AIDS dementia complex; ART = antiretroviral therapy; HIVE = HIV encephalitis; HMG-CoA = 3-hydroxy-3-methylglutaryl coenzyme A; LP = lumbar puncture; WBC = white blood cell.

Supported by National Institutes of Health R01 MH62701 and K23 MH074466, and the UCSF/SFGH CTSI Clinical Research Center (CCRC) and the Biostatistics, Research Ethics and Design Program (BREAD) programs supported by UL1 RR024131.

Disclosure: The authors report no disclosures.

Received January 25, 2008. Accepted in final form May 5, 2008.






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