Impact of an Antibiotic (Rifaximin) on Liver Scarring in HIV-Infected Patients With Liver Disease
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First Received Date ICMJE | July 30, 2012 | ||||||||
Last Updated Date | July 31, 2012 | ||||||||
Start Date ICMJE | August 2012 | ||||||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01654939 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Impact of an Antibiotic (Rifaximin) on Liver Scarring in HIV-Infected Patients With Liver Disease | ||||||||
Official Title ICMJE | Impact of Rifaximin on Liver Fibrosis in HIV-Infected Patients With Liver Disease | ||||||||
Brief 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 will be followed for one year. They will be included if they are starting on rifaximin, for its currently approved FDA indication (hepatic encephalopathy). |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 4 | ||||||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: Rifaximin
All patients will be taking rifaximin 550 mg twice daily for one year for a diagnosis of hepatic encephalopathy
Other Name: XIFAXAN |
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Study Arm (s) | Experimental: rifaximin
All patients will be taking rifaximin 550 mg twice daily
Intervention: Drug: Rifaximin |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE | 10 | ||||||||
Estimated Completion Date | September 2013 | ||||||||
Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01654939 | ||||||||
Other Study ID Numbers ICMJE | GCO 12-0794, HSM# 12-00436 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Douglas T. Dieterich, Mount Sinai School of Medicine | ||||||||
Study Sponsor ICMJE | Douglas T. Dieterich | ||||||||
Collaborators ICMJE | Salix Pharmaceuticals | ||||||||
Investigators ICMJE |
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Information Provided By | Mount Sinai School of Medicine | ||||||||
Verification Date | July 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |