好色先生

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Abstract Details

A Placebo Controlled Trial of Baricitinib in People on ART to Reduce CNS HIV
Infectious Disease
P1 - Poster Session 1 (8:00 AM-9:00 AM)
3-003
Reduce CSF HIV in people with HIV (PWH).
While antiretroviral treatment (ART) has reduced the severity of HIV cognitive impairment (HIV CI), brain remains a reservoir for HIV and mild HIV CI is common. HIV and neuroinflammation are drivers of HIV CI. Baricitinib, a JAK 1/2 inhibitor, has been shown to reduce the HIV macrophage reservoir in vitro and in a mouse HIV CI model. Baricitinib also reduced HIV-induced inflammation in mouse brains. These studies prompted a clinical trial in PWH virally controlled on ART.
64 PWH (18-65) on ART will be randomized to 2 mg daily of baricitinib or placebo given orally for 10 weeks. The primary endpoint is CSF HIV viral load with secondary endpoints including CSF and blood biomarkers (eg, IL-6), extensive neuropsychological testing, and 7T MRI including MR spectroscopy (MRS), collected before randomization and after 10 weeks of treatment. So far, correlations between baseline (prior to randomization) selected MRS and neuropsychological tests were analyzed for 20 participants.

So far, 21 participants have been randomized and 19 completed the study. The average age is 49, 42% are female, and 95% identify as Black. Increased myoinositol/creatine (mI/Cr) ratios in left frontal white matter correlated with decreased Digit Symbol Modalities Test scores (r=0.4415, p=0.051) and increased Trail Making Part B scores (r=0.496, p=0.026).
Preliminary baseline analyses demonstrate increased glial reaction in frontal white matter correlates with worsening cognitive test scores in PWH. Baseline data will be presented in a larger group of PWH including correlations between 7T MRI parameters, neuropsychological testing and a broad spectrum of serum and CSF biomarkers. We predict this data will provide important information characterizing brain imaging, cognitive function and systemic and CNS immunological parameters in our baseline study population randomized to a JAK inhibitor vs placebo to ultimately determine CNS HIV reduction in PWH.
Authors/Disclosures
William R. Tyor, MD, FAAN (Atlanta VAMC)
PRESENTER 		The institution of Dr. Tyor has received research support from NIH. The institution of Dr. Tyor has received research support from VHA. The institution of Dr. Tyor has received research support from NIH. The institution of Dr. Tyor has received research support from VHA. The institution of Dr. Tyor has received research support from NIH.
David W. Loring, PhD, FAAN Dr. Loring has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer Nature. Dr. Loring has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for ILAE. The institution of Dr. Loring has received research support from NIH. Dr. Loring has received publishing royalties from a publication relating to health care.
Taylor B. Harrison, MD (Emory University) Dr. Harrison has nothing to disclose.
MInh Ly T. Nguyen, MD Dr. Nguyen has nothing to disclose.
Ryan Peterson (Emory University School of Medicine) Ryan Peterson has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Flaherty Sensabaugh Bonasso.
Kaundinya Gopinath, PhD Dr. Gopinath has nothing to disclose.
Howard Pope (Emory University School of Medicine) No disclosure on file
Alicarmen Alvarez, RN Ms. Alvarez has nothing to disclose.
Kirk A. Easley, MApStat The institution of Prof. Easley has received research support from Emory University.
Vincent Marconi, MD Dr. Marconi has nothing to disclose.
Christina Gavegnano, PhD Dr. Gavegnano has nothing to disclose.
Candace C. Fleischer, PhD An immediate family member of Dr. Fleischer has stock in Greenlight. The institution of Dr. Fleischer has received research support from NIH. Dr. Fleischer has received personal compensation in the range of $500-$4,999 for serving as a Reviewer with NIH. Dr. Fleischer has received personal compensation in the range of $500-$4,999 for serving as a Speaker with ISMRM.