Inflammation in HIV Infection Clinical Trial
Official title:
Anti-Inflammatory Effects of Arabinoxylan Rice Bran Supplementation in Participants With Treated, Suppressed HIV Infection and Inadequate Immune Reconstitution
Double-blind placebo-controlled randomized trial of Arabinoxylan Rice Bran Supplementation for 12 weeks with BRM4 in HIV-infected participants with inadequate immune reconstitution.
Rationale: HIV infected persons have greater levels of inflammation and immune activation compared to the general population and are at greater risk of developing coronary heart disease (CHD) and other inflammation-associated co-morbidities. Intervention with BRM4 (Arabinoxylan Rice Bran Supplementation) in this population with impaired immune reconstitution may improve inflammation by a variety of mechanisms. Intervention: Arabinoxylan Rice Bran Supplementation with BRM4, is a nutritional supplement marketed in the US. It is composed of dietary fiber obtained from a denatured hemicellulose that is obtained by reacting rice bran hemicellulose with multiple carbohydrate hydrolyzing enzymes from Shiitake mushrooms. Objectives: The primary objective is to evaluate if 12 weeks of supplementation with arabinoxylan rice bran can safely reduce markers of inflammation during ART-suppressed HIV infection and thus potentially reduce the potential to develop end-organ disease in this group of at-risk patients. Study population: HIV-infected participants (≥18 years of age) who have been on stable ART for at least 24 weeks prior to study entry, and have impaired immune reconstitution defined as a CD4+ T-cell count 100-350 cells/mm3 prior to study entry, with plasma HIV-1 RNA <50 copies/mL. In order to assure 24 evaluable subjects, the investigators will enroll 28 subjects total (assuming 15% lost to follow-up rate). Study methodology: Randomized, double blind, placebo controlled clinical trial Description of study arms: At entry participants will be randomized to one of the following arms: Arm 1: BRM4 two 500mg capsules thrice daily p.o. for 12 weeks Arm 2: Placebo for Biobran two capsules thrice daily p.o. for 12 weeks Study endpoints: Primary - changes in sCD14 levels after 12 weeks of intervention. Secondary - week 12 changes in other inflammatory markers, microbial translocation, T-cell counts, and metabolic variables. Follow-up: Participants will not be followed after study completion, unless follow-up is necessary for an adverse event. Statistics: A total sample of 24 evaluable subjects (12 per arm) is needed to detect a clinically relevant difference of 0.07 log10 in sCD14 levels between treatment vs. placebo arms with 90% power and a 0.05 two-sided type I error rate. Plans for analysis: For the primary analysis, changes in sCD14 (and other biomarkers) from baseline to week 12 will be compared between the treatment arm and the placebo arm by a two-sided, two-sample t-test. ;