Probiotic To Be Studied in People Living with HIV

the Infectious Disease Advisor take:

ExeGi Pharma has announced participation in a clinical trial funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to study the probiotic Visbiome in people living with HIV. 

Conducted by the NIH-funded AIDS Clinical Trials Group (ACTG), the study will evaluate the safety, tolerability and effect of probiotics on the gut microbiome and immune activation markers in people living with HIV who are currently on suppressive antiretroviral therapy (ART), according to a press release from the company. 

In this study, researchers will examine whether alterations to the intestinal microbial environment can affect key markers of disease progression. 

Visbiome is the generic formulation VSL#3, which has been shown effective in the dietary management of patients with ulcerative colitis, irritable bowel syndrome (IBS) and pouchitis.

The study is a nine-month-long, prospective, randomized, placebo-controlled clinical trial. ACTG sites throughout the United States will recruit study participants. The ACTG network is one of the largest international cooperative groups focused on HIV research, with over 59 research sites around the world. The ACTG, established in 1987, has played a key role in the development and optimization of treatment for HIV infection.

“This study builds on previous research in which the immune defects of HIV are related to effects of the virus on the lymphoid tissue in the gastrointestinal tract and the subsequent alterations in the intestinal microbiome,” said Adriana Andrade MD, MPH, FACP, Associate Professor of Medicine at Johns Hopkins Hospital said in the press release. “The results of this study will provide novel insights about the potential for probiotics to improve immune function and decrease intestinal and systemic inflammation, important drivers for disease in people living with HIV,” added fellow investigator, Edgar Turner Overton MD, Associate Professor of Medicine at the University of Alabama at Birmingham.