The Role of Probiotics in HIV Patients With Immunological Non-Responder

Summary

This study will address HIV patients who are on antiretroviral treatment (ART) and experiencing immunological failure. The cause of immunological failure in HIV patients could be due to several factors such as age, gender, Cluster of Differentiation (CD4)+ count before started treatment and some inflammation in the gut. The C-C Chemokine Receptor 5 (CCR5) receptor on T lymphocyte CD4+ are abundantly found in the gut and attacked by HIV virus during acute infection causing irreversible damage. The disruption of gut integrity and chronic inflammation further causing translocation of bacteria in gut lumen to the blood. Thus resulting persistent low CD4+ or immunological failure. This evaluation plan is designed to establish the role of investigation product (probiotics) to improve gut inflammation in HIV patients.

Timeline

Start

2018-05-07

Primary completion

2018-12-27

Completion

2018-12-27

Outcome

Met primary endpoint

registry analysis (superiority test); Probiotics Rillus® vs Placebo; p = 0.02; Mean Difference (Net) 111.8 (95% CI 40.9 to 182.7); ANCOVA NCT03568812 ↗

Drugs

Indications