Impact of an Antibiotic (Rifaximin) on Liver Scarring in HIV-Infected Patients With Liver Disease
Status:
Withdrawn
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
For HIV-infected patients who have access to treatment, liver diseases are a major cause of
morbidity and mortality. Hepatitis C is the most frequently encountered liver condition in
this population. Both diseases allow a higher level of poisonous substances (toxins) normally
produced by the bacteria present in the gut to enter the bloodstream. This leads to a chronic
inflammatory state, which results in faster development of liver scars (fibrosis) and
ultimately, end stage disease (cirrhosis). To prevent this from happening, the use of
antibiotics has been attempted to reduce the quantity of gut flora in the hopes of lowering
the amount of toxins produced. These trials have shown promising results, but the antibiotics
studied had major side effects and were not designed for continuous use. Rifaximin is a non
absorbable antibiotic with very few side effects. It is already used for long periods of time
in cirrhotic patients to treat the effects of cirrhosis on the brain (encephalopathy). This
project will try to determine if rifaximin, by reducing the level of toxins produced by the
bacteria in the gut, can improve the evolution of liver fibrosis in HIV-infected patients
with hepatitis C. In this pilot study, ten patients with HIV and HCV infection will be
followed for one year. In addition, 10 patients with HCV mono infection will also be
followed. Both populations will be included if they are starting on rifaximin, for its
currently approved FDA indication (hepatic encephalopathy).
Phase:
Phase 4
Details
Lead Sponsor:
Douglas T. Dieterich
Collaborators:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.