Study Stopped
Funding ended
Immunology of HIV and Alcoholic Hepatitis
Effects of Alcoholic Hepatitis on Immunological and Virological Profiles in HIV-Positive Patients
1 other identifier
observational
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2019
CompletedFirst Posted
Study publicly available on registry
May 15, 2019
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedJanuary 22, 2021
January 1, 2021
3 months
May 14, 2019
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Immune activation - Levels of sCD14, sCD163
Levels of sCD14, sCD163
One year
Study Arms (2)
With alcoholic hepatitis
HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers with high bilirubin and AST levels.
Without alcoholic hepatitis
HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers without high bilirubin and AST levels.
Interventions
Alcoholic hepatitis is defined as having a total bilirubin level \>3mg/dL and AST level\>50U/L
Normal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly
Eligibility Criteria
40 patients with HIV infection who are receiving antiretroviral therapy and who are heavy drinkers.
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Infectious Diseases Research Center
Indianapolis, Indiana, 46202, United States
Biospecimen
PBMC, plasma, serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
May 14, 2019
First Posted
May 15, 2019
Study Start
July 1, 2020
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
January 22, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share