Impact of an Antibiotic (Rifaximin) on Liver Scarring in HIV-Infected Patients With Liver Disease
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/26/2015 |
| Start Date: | October 2012 |
| End Date: | September 2013 |
| Contact: | Douglas T Dieterich, MD |
| Email: | douglas.dieterich@mountsinai.org |
| Phone: | 212-241-7270 |
Impact of Rifaximin on Liver Fibrosis in HIV-Infected Patients With Liver Disease
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 will be followed
for one year. They will be included if they are starting on rifaximin, for its currently
approved FDA indication (hepatic encephalopathy).
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 will be followed
for one year. They will be included if they are starting on rifaximin, for its currently
approved FDA indication (hepatic encephalopathy).
Many studies have already proved the deleterious effects of LPS on HIV and hepatic diseases
evolution. There has never been a concerted effort to prevent the progression of liver
disease in these patients. To date, the only treatment is initiation of antiretroviral
therapy. Rifaximin could be an easy and well tolerated way to improve the outcome of liver
disease in HIV-infected patients. We hypothesize that it could help to slow down the
progression of liver disease at any stage in these patients. This is a pilot study. Ten
patients placed on rifaximin by their physician for a mild hepatic encephalopathy will be
monitored over a period of one year. The evaluation of the fibrosis will be done through
transient elastography every 3 months. Bacterial translocation will be evaluated through the
dosing of soluble CD14. The safety of the prolonged use of rifaximin in HIV-infected
patients will also be assessed.
evolution. There has never been a concerted effort to prevent the progression of liver
disease in these patients. To date, the only treatment is initiation of antiretroviral
therapy. Rifaximin could be an easy and well tolerated way to improve the outcome of liver
disease in HIV-infected patients. We hypothesize that it could help to slow down the
progression of liver disease at any stage in these patients. This is a pilot study. Ten
patients placed on rifaximin by their physician for a mild hepatic encephalopathy will be
monitored over a period of one year. The evaluation of the fibrosis will be done through
transient elastography every 3 months. Bacterial translocation will be evaluated through the
dosing of soluble CD14. The safety of the prolonged use of rifaximin in HIV-infected
patients will also be assessed.
Inclusion Criteria:
- Patients aged over 18 years old that can give an informed consent
- HIV-infected patients with hepatitis C associated liver disease demonstrated by a
fibroscan score above 8 kiloPascals
- Patients placed on rifaximin by their physician for a mild hepatic encephalopathy
Exclusion Criteria:
- Any patient unable to give informed consent.
- Patients on hepatitis C treatment
- Patients allergic to rifaximin or rifamycin
- Patients on any prolonged antibiotic treatment including patients on tuberculosis
treatment.
- Patients with history of Clostridium difficile infection
- Uncontrolled HIV infection: CD4 less than 200 or detectable viral load Patients need
to be on a stable ART regimen for at least one month.
- Patient on a HIV regimen including an unboosted protease inhibitor.
- Acute hepatitis of any cause.
- Child C cirrhosis
- Patients on dialysis
- Pregnant women or childbearing age women not accepting to use an effective
contraceptive method Acceptable methods are double barrier methods (condom with
spermicide jelly or diaphragm with spermicide), hormonal methods (oral
contraceptives, patches or medroxyprogesterone acetate), or an intrauterine device
with a documented failure rate of less than 1% per year. Females who have been
surgically sterilized (e.g., hysterectomy or bilateral tubal ligation) or who are
postmenopausal (total cessation of menses for >1 year) will not be considered
"females of childbearing potential."
- Usual exclusion criteria for FibroScan (pregnancy, BMI over 40, ascites, pacemaker or
defibrillator).
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