LM11A-31 for Cognitive Dysfunction in HIV

(LM11A31HAND Trial)

HIV rapidly infects the nervous system resulting in chronic infection that persists even when blood HIV is undetectable. The resulting inflammation causes progressive neuronal damage leading to cognitive decline in up to 50% of people living with HIV. The damage to the nervous system is due in part to a loss of natural processes that protect the brain. There are currently no effective treatments. A novel new drug, LM11A-31, has been shown to restore the protective processes thereby shifting the balance from degenerative to protective activity. Beneficial effects have been seen in patients with Alzheimer's disease and research indicates that it should have similar beneficial effects in people living with HIV. The proposed study will establish the safety and tolerability of LM11A-31 treatment in a small cohort of stable virally-suppressed participants with HIV and mild neurocognitive impairment. The focus will be on individuals 50-75 years of age who are most vulnerable for cognitive decline. To provide sufficient time to stabilize brain activity, participants will take tablets twice daily over a period of 48 weeks. The main focus of the trial will be on safety but will also be supplemented with exploratory characterization of biomarkers to confirm a reduction in degeneration as well as to provide early identification of individuals at risk for neurodegeneration. These studies are expected to show that LM11A-31 is safe to use in people living with HIV and to provide preliminary data indicating protection from neuronal damage and cognitive decline.