Clinical Research Unit
This program includes a clinical research unit, embedded within the ID/HIV clinical practice, that conducts a portfolio of clinical trials and observational studies. The studies supported include investigator-initiated trials as well as participation in multi-center trials conducted within NIH- or industry-funded networks.
Studies
BFocus Trial
The BFocus trial is an international phase 3 clinical trial of a novel drug, bepirovirsen in treating those with HBV and HIV coinfection to determine if functional cure for HBV in persons living can be achieved after 24 weeks of treatment for those on stable ART (antiretroviral therapy) for HIV. Bepirovirsen disrupts the body’s production of key viral proteins involved in hepatitis B surface antigen production, thereby allowing the body to fight the HBV infection. Reducing the body's production of hepatitis B surface antigen allows the body to gain full control over the HBV infection in order to fully suppress the hepatitis B viral load thereby acheiving a functional cure of chronic hepatitis B. In a phase 2 trial (B-Clear) 9% of participants had a sustained virological response (HbsAg and HBV DNA below the lower limits of quantification) suggesting great promise with this new therapeutic agent to functionally cure HBV. This study is intended to evaluate the efficacy, safety, and PK profile of bepirovirsen 300 mg weekly for 24 weeks (with loading doses) compared to placebo in an HIV/HBV coinfection population on HBV and HIV-active ART.
BWELL2
BWell2 Trial is an international Phase 3 clinical trial involving 859 participants globally that evaluates a novel drug, bepirovirsen in achieving functional cure of hepatitis B by disrupting the body's production of key viral proteins in producing hepatitis B surface antigen, which are responsible for chronic infection among persons living with chronic hepatitis B. In doing so, bepirovirsen holds great promise to allow persons living with chronic hepatitis B to stop their daily, lifelong nucleos(t)ide treatments for chronic hepatitis B by allowing the body to gain full control over the viral proteins and hepatitis B surface antigen in the absence of daily medication. Early trials of this drug (BClear) have shown promise for functional cure in 9% of participants. The BWell2 study has 4 stages: 1) Double-blind treatment (bepirovirsen or placebo) for 24 weeks, 2) Nucleos(t)ide analogue (NA) treatment for 24 weeks, 3) NA cessation stage OR Continue NA for 24 weeks, and finally 4) Assessment of durability of response and follow up for further 24 weeks for participants who stopped NA treatment at week 48.
Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults living with HIV (‘HiActivity’)
The long-term goal of this research is to develop an effective and efficient primary care intervention that increases lifestyle physical activity among older persons living with HIV. The current study is a randomized clinical trial designed to evaluate several behavioral interventions for their efficacy on improving physical activity as measured in ‘steps per day’ (the primary outcome). The goal is then to determine which components will be combined for a final optimized intervention package that will be studied in a large-scale definitive clinical trial. The study is being conducted at the HHRI (Minneapolis, MN) and Brown University (Providence, RI), where approximately 200 persons with HIV of age ≥50 years will be enrolled
Key Investigators
