The Department of Biostatistics’ Center for Biostatistics in AIDS Research (CBAR), directed by Professor Michael Hughes, has a broad research agenda on infectious diseases with a longstanding focus on HIV, tuberculosis and viral hepatitis research, now expanded to include COVID-19 and mpox (formerly known as monkeypox) research. Some highlights over the past year include:
- Work on several COVID-19 clinical trials including a novel international COVID-19 phase 2/3 adaptive platform clinical trial evaluating treatments to prevent hospitalization and death. Seven candidate agents were evaluated in the platform trial for their effects on acute disease, and are now being evaluated for their effects on long COVID. CBAR statisticians provided statistical leadership for a study which established adequate pharmacokinetics and safety of remdesivir treatment of COVID-19 in pregnant compared with non-pregnant women.
- Dr Summer Zheng led the statistical work on a pivotal ongoing trial set up to evaluate treatment for mpox in response to the emergent epidemic.
- CBAR houses the statistical centers for the international HIV clinical trials networks, the AIDS Clinical Trials Group (led by Professor Hughes) and the International Maternal Pediatric Adolescent Clinical Trials network (led by Dr David Shapiro). Of note this year, CBAR statisticians provided statistical leadership for two clinical trials that supported FDA approval of a new fixed-dose combination HIV treatment for children and the first long-acting HIV treatment for adolescents.
- The REPRIEVE clinical trial (reprievetrial.org), a global cardiovascular prevention trial in people living with HIV with the statistical center led by Dr Heather Ribaudo completed its 7thyear of follow-up and successfully secured funding for 2 additional years of follow-up.
- Paige Williams is a principal investigator for the Pediatric HIV/AIDS Cohort Study. Two new PHACS-associated observational cohort studies were opened: Trajectories of Emotional Regulation and Behavior Outcomes and Related Brain Regions and Intrinsic Networks (TERBO BRAIN) study, which will evaluate emotional and mental health of children and young adults in PHACS through brain neuroimaging studies and cognitive assessments; and the Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) study (co-PI: Dr Deborah Kacenek), to examine physical and mental health outcomes among women living with HIV.