The Rockefeller University

This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).

Type: Interventional

Start Date: Aug 2023

open study

Multiple sclerosis (MS) is a disease of the brain in which brain blood vessels and the fatty tissue that insulates nerve cells myelin are damaged. How these brain tissues are damaged remains unknown. We have identified a toxin that is produced by the intestinal bacterium Clostridium perfringens as a possible trigger for MS. This bacterial toxin named epsilon toxin specifically damages brain blood vessels and brain myelin. To attack the brain the toxin must travel from the intestine and into the bloodstream. Momentary presence of the toxin in the blood circulation may give us an opportunity to validate the epsilon toxin-MS hypothesis if we can identify epsilon toxin in blood samples harvested from MS patients during periods of active disease. Accurately determining the percentage of MS patients that actively carry Clostridium perfringens bacteria in their intestines may also provide important supporting evidence for the hypothesis. In this study we wish to collect blood and stool samples from MS patients in an effort to detect blood-borne epsilon toxin and fecal carriage of Clostridium perfringens bacteria. 

Type: Observational

open study

HIV-1 integrates into host cellular DNA and can persist in a latent state. Antiretroviral therapy (ART) might alter HIV-1 integration site selection. Current antiretroviral regimens are effective in lowering circulating HIV-1 RNA levels to less than 20 copies/ml but in approximately 50% of individuals persistent low-level viremia can be detected despite years of suppressive ART. Moreover as anti-HIV-1 immune responses develop during the course of infection HIV-1 strains mutate to escape both humoral and cellular immune responses. style=>This study aims at evaluating circulating HIV-1 RNA levels by a single copy assay as well as characterize the HIV latent reservoir including quantification of infected cells and analyzing HIV-1 integration patterns of untreated and ART-treated participants. We will also evaluate the presence of cell-free HIV-1 DNA in plasma from people living with HIV which can serve as a biomarker of HIV-1-induced cell death. Lastly the study also aims at evaluating the sensitivity of viral strains to anti-HIV-1 broadly neutralizing antibodies.

Type: Observational

open study