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CTNPT 024: Non-alcoholic steatohepatitis in HIV mono-infection

Use of non-invasive methods for diagnosis of non-alcoholic steatohepatitis (NASH) in HIV patients and therapeutic use of vitamin E

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About the study

This pilot study will explore the use of non-invasive methods to diagnose nonalcoholic steatohepatitis (NASH) in people living with HIV. NASH is a disease of the liver that leads to cirrhosis. With liver-related death on the rise and liver transplantation severely limited for people living with HIV, diagnosing NASH early and distinguishing it from simple fatty liver are critical issues.

The researchers will also test to see if a six-month treatment of vitamin E supplementation can improve diagnostic results and metabolic and liver function of participants. The study researchers are looking to help pave the way for a larger interventional randomized controlled trial of vitamin E treatment for people living with HIV and NASH.

About the disease/condition

Although AIDS-related death has fallen drastically since the introduction of effective antiretroviral therapy, the proportion of deaths from HIV-related conditions has increased. Individuals living with HIV often experience common health conditions, such as obesity and diabetes, and are often at increased risk of developing non-alcoholic fatty liver disease (NAFLD). NAFLD in turn can develop into NASH.

Traditional testing and treatment for NASH is both expensive, invasive and hard to come by. As such, a faster, more affordable method of detecting NASH in individuals living with HIV is essential. Furthermore, the use of vitamin E as treatment for NASH in HIV-infected people has not yet been sufficiently tested.

Study Approach

First, potential patients will be screened for HIV and NASH, including and a blood draw, laboratory testing, and a complete clinical examination to ensure compliance with the criteria. Those fulfilling the criteria will then be tested several more times to see the progression of their HIV and NASH over a six-month period. Study participants will also be taking vitamin E daily as a potential treatment for NASH during this time. Finally, there will be a follow-up visit six months after the conclusion of the initial six-month period.

Eligibility criteria

Inclusion Criteria:

  • Confirmed HIV mono-infection
  • 18 years or older
  • Able to provide informed consent, signing forms available in French or English.
  • Non-invasive diagnosis of NASH based on a serum biomarker and a new ultrasound-based test

Exclusion Criteria:

  • Co-infection with HCV or HBV, liver transplantation
  • Significant alcohol consumption; >21 drinks on average per week in men and >14 drinks on average per week in women
  • Patients taking anticoagulants (warfarin, heparin)
  • Patients undergoing chemotherapy or radiotherapy for cancer
  • History of diagnosis of prostate cancer
  • Planning to become, suspected to be, pregnant or breastfeeding

Participating sites

Quebec
Chronic Viral Illness Service
Montreal Chest Institute/McGill University Health Centre
1001 Decarie Blvd
Montreal, H4A 3J1

Additional Information

If you would like more information on this clinical study, please refer to the participating site.

Principal Investigator:

Dr. Giada Sebastiani
Chronic Viral Illness Service
514-843-2090

Publication:

Sebastiani G, Rollet-Kurhajec KC, Pexos C, Gilmore N, Klein MB. Incidence and predictors of hepatic steatosis and fibrosis by serum biomarkers in a large cohort of human immunodeficiency virus mono-infected patients. Open Forum Infect Dis. 2015;2(1):ofv015.

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