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Immunology of HIV and Alcoholic Hepatitis

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ClinicalTrials.gov Identifier: NCT03951662
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Samir K Gupta, MD, MS, Indiana University

Brief Summary:
This is prospective, longitudinal cohort study involving HIV-positive, antiretroviral (ART)-treated, heavy alcohol drinking participants who have and do not have alcoholic hepatitis.

Condition or disease Intervention/treatment
HIV/AIDS Alcoholic Hepatitis Other: Alcoholic Hepatitis Group Other: Heavy Drinking Controls without Hepatitis

Detailed Description:
The primary objective of this study is to determine the relationships between alcohol consumption and HIV-related pathogenic processes (microbial translocation, immune activation, inflammation, HIV replication, and hepatitis). Two study groups will be assembled and followed longitudinally over one year to address this objective. Group 1 will include HIV-positive, ART-treated, heavy alcohol drinkers who have alcoholic hepatitis. Group 2 will include HIV-positive, ART-treated, heavy alcohol drinkers who do not have alcoholic hepatitis. Both groups will undergo similar study procedures and follow-up.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Alcoholic Hepatitis on Immunological and Virological Profiles in HIV-Positive Patients
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
With alcoholic hepatitis
HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers with high bilirubin and AST levels.
Other: Alcoholic Hepatitis Group
Alcoholic hepatitis is defined as having a total bilirubin level >3mg/dL and AST level>50U/L

Without alcoholic hepatitis
HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers without high bilirubin and AST levels.
Other: Heavy Drinking Controls without Hepatitis
Normal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly




Primary Outcome Measures :
  1. Immune activation - Levels of sCD14, sCD163 [ Time Frame: One year ]
    Levels of sCD14, sCD163


Biospecimen Retention:   Samples Without DNA
PBMC, plasma, serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
40 patients with HIV infection who are receiving antiretroviral therapy and who are heavy drinkers.
Criteria

Inclusion Criteria:

  • Both Groups: Age equal to or greater than 18 years
  • HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot, a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by at least one detectable HIV-1 RNA level
  • Receipt of stable antiretroviral therapy of any kind for at least 90 days prior to the baseline study visit
  • The most recent HIV-1 RNA level must be <200 copies/mL obtained as part of routine clinical care within 90 days prior to the main study visit
  • NOTE: There is no CD4 cell count eligibility criterion for this study.
  • Current alcoholism defined as >40g/day and >60g/day of alcoholic intake on average for a minimum of six months and within 90 days of the baseline visit in women and men, respectively
  • For Group 1 (Alcoholic Hepatitis Group), the presence of alcoholic hepatitis is defined by

    • Per most recently obtained routine clinical care laboratories, a total bilirubin > 3mg/dL and AST >50U/L, both within 90 days of the baseline study visit
    • For Group 1, participants who have become alcohol abstinent within 14 days of the baseline visit will still be allowed to participate
  • For Group 2 (Heavy drinking controls without hepatitis):

    • The most recent AST, ALT, and total bilirubin levels must be within normal limits. However, if the bilirubin level is increased due to suspected Gilbert's syndrome or due to current use of atazanavir, then the participant will be eligible.
    • There must not be evidence of current hepatosplenomegaly by examination or imaging obtained previously
    • There must not be stigmata of cirrhosis (spider angiomata, jaundice, encephalopathy, palmar erythema, ascites, intestinal varices).

Exclusion Criteria:

  • Inability to complete written, informed consent
  • Incarceration at the time of screening or main study visit
  • Abstinence from alcohol >2 weeks prior to the baseline study visit
  • Liver disease considered to be due to any etiology besides alcohol use
  • Diagnosed disease or process associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, other collagen vascular/autoimmune diseases)
  • Known active hepatitis B (defined as hepatitis B surface antigen positive with quantifiable HBV DNA viral load) or active hepatitis C (defined as quantifiable hepatitis C RNA viral load)
  • Fever, defined as T ≥ 38.0C within 48 hours prior to any study visit
  • Therapy for acute infection or other serious medical illnesses within 7 days of study visit
  • Malignancy requiring active treatment or had completed treatment within 90 days of any study visit (excluding skin-limited Kaposi sarcoma)
  • Pregnancy or breastfeeding within 14 days of any study visit
  • Receipt of investigational agents, cytotoxic chemotherapy, systemic or topical glucocorticoids (of any dose), or anabolic steroids (including physiologic testosterone replacement therapy) within 14 days of study visit
  • Active illicit drug use (besides marijuana) via any intake route (inhalation, smoking, injection)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951662


Contacts
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Contact: Paula A Johnson, NP 317-274-8473 johnpaul@iu.edu

Locations
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United States, Indiana
Infectious Diseases Research Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University

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Responsible Party: Samir K Gupta, MD, MS, Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03951662     History of Changes
Other Study ID Numbers: NIAAA 1UH2AA026218
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bilirubin
Hepatitis
Hepatitis A
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs