Rifaximin as a Modulator of Microbial Translocation and Immune Activation

Phase 2 Completed 73 enrolled Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is being done to see whether rifaximin, an antibiotic that works in the intestines, can lower the amount of germs in the intestines of HIV infected persons. It is possible that when the amount of these germs is lowered, an HIV-infected person's immune system will become less active and will have a better chance of recovering. Also, the study will evaluate the safety of using rifaximin in HIV-infected subjects.

Timeline

Start: 2011-09
Primary completion: 2012-09
Completion: 2012-11

Outcome

Met primary endpoint

registry MEDIAN Arm A: Treatment With Rifaximin: 0.00 (-1.70 to 1.00) percentage HLA-DR+/CD38+ of CD8+ NCT01466595 ↗

registry analysis (superiority or other test); Arm A: Treatment With Rifaximin vs Arm B: No Study Treatment; p = 0.028; Wilcoxon (Mann-Whitney); note: not adjusted for multiple comparisons NCT01466595 ↗

Publications

Tenorio AR, Chan ES, Bosch RJ, Macatangay BJ, Read SW, Yesmin S, Taiwo B, Margolis DM, Jacobson JM, Landay AL, Wilson CC; A5286 Team. Rifaximin has a marginal impact on microbial translocation, T-cell activation and inflammation in HIV-positive immune non-responders to antiretroviral therapy - ACTG A5286. J Infect Dis. 2015 Mar 1;211(5):780-90. doi: 10.1093/infdis/jiu515. Epub 2014 Sep 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rifaximin	Other / unclassified	550 mg	Oral