Resources The UR CTSI offers an annual Pilot Study Program, providing faculty and trainees one year of seed funding ($25,000 to $50,000) for highly innovative pilot projects; an Incubator Program, supporting two-year “super-pilot” projects for up to $250,000; Regulatory Support Services; Informatics Consultations; and a Research Help Desk.
Do Lifesaving Drugs Damage HIV Patients’ Brains? Some research suggests that lifesaving HIV drugs could damage patients’ brains, but early results from a clinical study conducted at the University of Rochester Clinical and Translational Science Institute’s (UR CTSI) Clinical Research Center suggests the opposite. Short-term use of combination antiretroviral therapy (cART) drugs improved mental function in HIV-infected individuals. Giovanni Schifitto, MD, MS, professor of Neurology at the University of Rochester Medical Center (URMC) and director of the UR CTSI’s Clinical Research Center, leads the clinical trial, which aims to understand the short- and long-term effects of cART on HIV patients’ brains. So far, the therapy appears to improve mental performance and functional connectivity in the brain with shortterm use. HIV patients often experience mental decline ranging from mild impairment to full-blown dementia. Experts have long debated the cause of that mental decline: HIV itself, or the drug used to treat it. While some of the first HIV drugs caused damage to peripheral
nerves, newer antiretroviral drugs are believed to be safer. But patients taking these drugs continue to experience mental impairment – even when they have very little virus in their blood. Some studies have even shown improvement in HIV patients’ mental function when they stop using cART. “But those studies were very indirect,” said Schifitto. “They studied cohorts of people who were already on medications, which makes it very hard to pull apart whether the virus or the drug is to blame for effects in the brain.” Schifitto’s study, on the other hand, followed 17 HIV-infected individuals who had not received any treatment prior to the study. These patients scored worse on mental function tests and brain imaging revealed fewer connections in their brains than the HIV-negative control group. After receiving cART for 12 weeks, the HIV patients’ mental performance and functional brain connectivity improved nearly to the level of the HIV-negative group. This suggests that short term cART use does not damage the brain, and that the virus is the culprit for HIV patients’ early mental impairment. However, this was just a first step of the study, which aims to enroll and follow more than 150 participants over two years. It is possible that cART could cause mental decline after
prolonged use and the team wants to track if and when that happens. They are also monitoring sleep, mood and several other factors that can impact mental function in HIV patients taking cART. In the end, the outcomes of the short- and long-term studies may help healthcare providers tailor cART cocktails and treatment schedules to individual patients’ needs. The results could also have implications for preventative use of cART in individuals who are at high risk for contracting HIV, a practice called pre-exposure prophylaxis, commonly call PrEP. While the study started at URMC, it now includes study sites at Cornell Medical Imaging Center, Gay Men’s Health Crisis, SUNY Upstate Medical, University at Buffalo and University of Texas Health Science Center at Houston.
UR CTSI Annual Report 2017–18
Annual report for the University of Rochester Clinical & Translational Science Institute.