- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03951662
Immunology of HIV and Alcoholic Hepatitis
January 20, 2021 updated by: Samir K Gupta, MD, MS, Indiana University
Effects of Alcoholic Hepatitis on Immunological and Virological Profiles in HIV-Positive Patients
This is prospective, longitudinal cohort study involving HIV-positive, antiretroviral (ART)-treated, heavy alcohol drinking participants who have and do not have alcoholic hepatitis.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Infectious Diseases Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
40 patients with HIV infection who are receiving antiretroviral therapy and who are heavy drinkers.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
With alcoholic hepatitis
HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers with high bilirubin and AST levels.
|
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.
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Normal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune activation - Levels of sCD14, sCD163
Time Frame: One year
|
Levels of sCD14, sCD163
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
May 14, 2019
First Submitted That Met QC Criteria
May 14, 2019
First Posted (Actual)
May 15, 2019
Study Record Updates
Last Update Posted (Actual)
January 22, 2021
Last Update Submitted That Met QC Criteria
January 20, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- RNA Virus Infections
- Virus Diseases
- Infections
- Liver Diseases
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Liver Diseases, Alcoholic
- Alcohol-Induced Disorders
- Hepatitis
- Hepatitis A
- Hepatitis, Alcoholic
Other Study ID Numbers
- NIAAA 1UH2AA026218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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