University Hospital conducts a Sequential Analysis Before and After Treatment Initiation to Unravel the Role of Naturally Occurring Extracellular Vesicles in HIV Infection

Photo by Bret Kavanaugh

University Hospital, Ghent is recruiting patients for the clinical trial of Sequential Analysis Before and After Treatment Initiation to Unravel the Role of Naturally Occurring Extracellular Vesicles in HIV Infection (Saturne-HIV).

This study aims to evaluate the role of extracellular vesicles in HIV-infection, by determining the expression profile and content of EVs before and after treatment initiation in HIV-infected patients, through extensive blood and tissue sampling (leukapheresis, stool sampling and colon biopsies). A one-time sampling (blood, stool, colon biopsies) will also be performed in HIV-seronegative healthy volunteers to confirm that results found in HIV-infected patients are related to the disease.

The researcher's aim is to enroll a minimum of 32 and a maximum of 50 untreated HIV-infected patients. They aim to include a minimum of 16 patients with a CD4 T cell count lower than 350 cells/µl and a minimum of 16 patients with a CD4 T cell count higher than 350 cells/µl. Furthermore we aim to include 16 HIV-seronegative healthy donors to confirm that the results found in HIV-patients are related to the disease.

The researchers plan that December 2020 will be the study start date. The indicative completion of the clinical trial will be expected in January 2025.

Among primary outcome measures are the Extracellular Vesicles analysis-PCR and the isolated EVs will be further characterized through PCR.

Among the inclusion criteria are:

  • Documented untreated HIV-1 infection defined as followed: HIV-1-specific antibody+(western blot); p31+ (ELISA).
  • CD4 T cell count will be determined standard of care (SOC). A minimum of 16 patients will be included with a CD4 T cell count lower than 350 cells/µl and a minimum of 16 patients with a CD4 T cell count higher than 350 cells/µl.
  • Age ≥ 18 years and ≤ 65 years.
  • Ability to attend the complete schedule of assessments and patient visits as described in the schedule below.
  • Ability and willingness to have blood, stool and colon samples collected and stored for 20 years after finalizing the study, and used for various research purposes.

The study will take place at the Ghent University Hospital, Ghent, Oost-Vlaanderen, Belgium.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04653610

Clinical Research News

Upcoming Clinical Trials

3