Immunology of HIV and Alcoholic Hepatitis

NCT ID: NCT03951662

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-09-30

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.

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.

Conditions

HIV/AIDS; Alcoholic Hepatitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

With alcoholic hepatitis

HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers with high bilirubin and AST levels.

Alcoholic Hepatitis Group

Intervention Type: OTHER

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.

Heavy Drinking Controls without Hepatitis

Intervention Type: OTHER

Normal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly

Interventions

Alcoholic Hepatitis Group

Alcoholic hepatitis is defined as having a total bilirubin level \>3mg/dL and AST level\>50U/L

Intervention Type: OTHER

Heavy Drinking Controls without Hepatitis

Normal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Samir K Gupta, MD, MS

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Infectious Diseases Research Center

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

NIAAA 1UH2AA026218

Identifier Type: -

Identifier Source: org_study_id