Impact of an Antibiotic (Rifaximin) on Liver Scarring in HIV-Infected Patients With Liver Disease

NCT01654939 | Withdrawn Phase 4

• 2 other identifiers: GCO 12-0794HSM# 12-00436
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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).

Conditions

HIV; Hepatitis C

Keywords

HIV; hepatitis C

Outcome Measures

Primary Outcomes (5)

• Liver fibrosis progression as measured by transient elastography

  Transient elastography is a non invasive way to measure liver stiffness. It is not FDA-approved and is used as a research tool in this study.

  Baseline

• Liver fibrosis progression as measured by transient elastography

  Transient elastography is a non invasive way to measure liver stiffness. It is not FDA-approved and is used as a research tool in this study.

  3 months

• Liver fibrosis progression as measured by transient elastography

  Transient elastography is a non invasive way to measure liver stiffness. It is not FDA-approved and is used as a research tool in this study.

  6 months

• Liver fibrosis progression as measured by transient elastography

  Transient elastography is a non invasive way to measure liver stiffness. It is not FDA-approved and is used as a research tool in this study.

  9 months

• Liver fibrosis progression as measured by transient elastography

  Transient elastography is a non invasive way to measure liver stiffness. It is not FDA-approved and is used as a research tool in this study.

  12 months

Secondary Outcomes (6)

• Levels of sCD14 in HIV-infected patients with liver disease and HCV infected patients taking rifaximin

  Baseline

• Levels of sCD14 in HIV-infected patients with liver disease and HCV infected patients taking rifaximin

  1 month

• Levels of sCD14 in HIV-infected patients with liver disease and HCV infected patients taking rifaximin

  3 months

• Levels of sCD14 in HIV-infected patients with liver disease and HCV infected patients taking rifaximin

  6 months

• Levels of sCD14 in HIV-infected patients with liver disease and HCV infected patients taking rifaximin

  12 months

Study Arms (1)

rifaximin

EXPERIMENTAL

All patients will be taking rifaximin 550 mg twice daily

Drug: Rifaximin

Interventions

Rifaximin DRUG

All patients will be taking rifaximin 550 mg twice daily for one year for a diagnosis of hepatic encephalopathy

Also known as: XIFAXAN

rifaximin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• HCV infected patients with liver disease demonstrated by a fibroscan score above 8 kiloPascals
• Patients placed on rifaximin by their physician for a mild hepatic encephalopathy

You may not qualify if:

• 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."

Sponsors & Collaborators

• Douglas T. Dieterich: lead
• Bausch Health Americas, Inc.: collaborator

MeSH Terms

Conditions

Hepatitis C

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Douglas T Dieterich, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: September 28, 2015

Record last verified: 2015-09