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HIVPhase 4NCT01654939

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

A Phase 4 study testing Rifaximin in people with HIV and Hepatitis C, run by Douglas T. Dieterich.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV, Hepatitis C
What is being tested?
Rifaximin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2012to Sep 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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).

About this study

Official title: 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 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).

Read the 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. A total of twenty 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 patients will also be assessed.

Conditions
HIV, Hepatitis C
Being tested
Rifaximin
Keywords
HIV, hepatitis C
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RifaximinDrug

    Also called XIFAXAN

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

Study groups in NCT01654939
Study groupRoleWhat they receive
rifaximinExperimentalAll patients will be taking rifaximin 550 mg twice daily
Receives: Drug: Rifaximin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 9 months

  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.

    Measured: 12 months

Secondary outcomes (6)

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

    sCD14 is a surrogate marker of bacterial translocation

    Measured: Baseline

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

    sCD14 is a surrogate marker of bacterial translocation

    Measured: 1 month

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

    sCD14 is a surrogate marker of bacterial translocation

    Measured: 3 months

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

    sCD14 is a surrogate marker of bacterial translocation

    Measured: 6 months

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

    sCD14 is a surrogate marker of bacterial translocation

    Measured: 12 months

  6. Safety of prolonged use of rifaximin in HIV patients taking many other medications

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionSep 2014
  4. Study completionSep 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01654939
Sponsor's protocol ID
GCO 12-0794
Other IDs
HSM# 12-00436
Status last verified
Sep 2015
First submitted
30 Jul 2012
Last updated
28 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rifaximin in people with HIV and Hepatitis C, run by Douglas T. Dieterich.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver fibrosis progression as measured by transient elastography (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01654939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.

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