Lactoferrin modulates mucosal immunity and targets mechanisms contributing to inflammation during human immunodeficiency virus disease. A randomized placebo-controlled crossover clinical trial of recombinant human (rh) lactoferrin was conducted among 54 human immunodeficiency virus-infected participants with viral suppression. Outcomes were tolerability, inflammatory, and immunologic measures, and the intestinal microbiome. The median age was 51 years, and the median CD4+ cell count was 651/μ L. Adherence and adverse events did not differ between rh-lactoferrin and placebo. There was no significant effect on plasma interleukin-6 or D-dimer levels, nor on monocyte/T-cell activation, mucosal integrity, or intestinal microbiota diversity. Oral administration of rh-lactoferrin was safe but did not reduce inflammation and immune activation.
Bibliographical noteFunding Information:
Financial support. This work was supported by Hennepin Health Services (career development award), the intramural research program of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), the National Cancer Institute, NIH (contract HHSN261200800001E), the intramural research program of NIAID/NIH and the NIAID microbiome core facility, and Ventria Bioscience (provision of study drug, including both active rh-lactoferrin tablets and matching placebo).
- Immune activation