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SteatohepatitisNCT00575757

Relationship of Metabolic Abnormalities to Hepatic Steatosis in HIV

An observational study of Steatohepatitis, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Because NASH is now recognized as a significant cause of cirrhosis with associated morbidity and mortality, its recognition as a long term complication of HAART is important to the management of those living with HIV. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Steatohepatitis
How many people
12 participants
Where
1 siteUnited States
Study dates
Jul 2007to Jul 2016
Phase
Observational
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HIV positive with abnormal liver enzymes in the absence of HCV/HBV coinfections.

Who may be able to join

  • HIV antibody positive.
  • Age > 18 years
  • Abnormal liver chemistries (AST, ALT, and/or ALP) defined as between 1.25 -5 x ULN.

Who cannot join

  • Hepatic decompensation: coagulopathy (prothrombin time prolonged > 2 seconds, INR > 1.5), ascites, hepatic encephalopathy, jaundice (serum conjugated bilirubin > 3.0)
  • Thrombocytopenia (platelets < 80,000)
  • Use of vitamin E, thiazolidinediones, metformin
  • Use of medications associated with steatosis: amiodarone, methotrexate, corticosteroids, estrogen, and tamoxifen
  • Renal failure (serum creatinine > 3.0)
  • Diabetes mellitus
Show all 11Show fewer
  • Advanced HIV disease with life expectancy less than 1 year
  • Alcohol use (> 40 grams/day in men and 20 grams/day in women)
  • Presence of HCV RNA or HBV surface antigen
  • Other liver diseases including alpha-1 antitrypsin (A1AT) deficiency, autoimmune hepatitis, hemochromatosis, Wilson's disease, HIV cholangiopathy, bacillary angiomatosis, lymphoma, and Kaposi's sarcoma
  • Inability to give informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Virgnia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

Because NASH is now recognized as a significant cause of cirrhosis with associated morbidity and mortality, its recognition as a long term complication of HAART is important to the management of those living with HIV.

Read the detailed description

Abnormal liver enzymes are frequently seen in those with HIV. Although many of these individuals are co-infected with HBV or HCV, histology in HIV patients with abnormal liver enzymes in the absence of viral hepatitis has not been explored. HAART has significantly improved the survival in those living with HIV. However, components of HAART, particularly protease inhibitors (PIs) and certain nucleoside reverse transcriptase inhibitors (NRTIs), are frequently associated with metabolic abnormalities including insulin resistance (IR), dyslipidemias, fat redistribution and lipodystrophy (LD). Both IR and dyslipidemia are pathogenic mechanisms associated with nonalcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) which often present as asymptomatic liver enzyme elevations. Because NASH is now recognized as a significant cause of cirrhosis with associated morbidity and mortality, its recognition as a long term complication of HAART is important to the management of those living with HIV. In our HIV population without HCV or HBV, there is a higher prevalence of abnormal liver enzymes (AST 21%, ALT 16%, ALP 43%) compared to the general population (ALT 8%) and is independently associated with PI use. The relationship of liver enzyme abnormalities to IR, dyslipidemias, and the development hepatic steatosis/NASH in HIV patients is unknown. We hypothesize that Liver enzyme abnormalities in HIV positive patients without viral hepatitis co-infections on HAART are due to hepatic steatosis related to PI use and that a subset of these individuals has NASH. The Specific Aims focus on HIV positive patients with abnormal liver enzymes in the absence of viral hepatitis co-infections, diabetes, or alcohol abuse to answer the following three questions: (1) What is the spectrum of NAFLD?; (2) How does the spectrum compare in those that are on a PI compare to those that are not; and (3) What are the independent predictive factors associated with hepatic steatosis and NASH? These studies will (1) provide novel data on the histology of HIV infected patients with abnormal liver enzymes in the absence of viral coinfections and their relationship to IR, LD, dyslipidemias, and HAART use and (2) provide the necessary pilot data for a multicenter R0-1 grant to study the long-term impact of HAART on the development of steatohepatitis and subsequent hepatic fibrosis.

Conditions
Steatohepatitis
Keywords
Steatosis, NASH
Medical subject headings
Fatty Liver

What participants receive

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

Study groups in NCT00575757
Study groupRoleWhat they receive
PrimaryHIV infected with abnormal liver enzymes in the absence of HCV or HBV coinfections.

What is being measured

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

  1. What is the spectrum of NAFLD in HIV

    Measured: 2 years

Secondary outcomes (2)
  1. How does the spectrum compare in those that are on a PI compare to those that are not.

    Measured: 2 years

  2. What are the independent predictive factors associated with hepatic steatosis and NASH?

    Measured: 2 years

Timeline

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

  1. First posted18 Dec 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00575757
Sponsor's protocol ID
VCUHM10107
Other IDs
1R03DK075416-01
Status last verified
Aug 2016
First submitted
14 Dec 2007
Last updated
18 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Sterling RK, Smith PG, Brunt EM. Hepatic steatosis in human immunodeficiency virus: a prospective study in patients without viral hepatitis, diabetes, or alcohol abuse. J Clin Gastroenterol. 2013 Feb;47(2):182-7. doi: 10.1097/MCG.0b013e318264181d.

    PubMed 23059409

Questions about this trial

What is this clinical trial studying?

An observational study of Steatohepatitis, run by Virginia Commonwealth University at 1 site in United States.

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 3 inclusion and 11 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: finished, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

What is the spectrum of NAFLD in HIV (time frame: 2 years). 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 NCT00575757, which also lists 1 linked publication.

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 18 Aug 2016.

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