HIV/AIDSNCT03951662
Immunology of HIV and Alcoholic Hepatitis
An observational study of HIV/AIDS and Alcoholic Hepatitis, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Alcoholic Hepatitis
- What is being tested?
- Alcoholic Hepatitis Group
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 30 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 patients with HIV infection who are receiving antiretroviral therapy and who are heavy drinkers.
Who may be able to join
- 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
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- 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).
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Infectious Diseases Research Center
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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
- Being tested
- Alcoholic Hepatitis Group, Heavy Drinking Controls without Hepatitis
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcoholic Hepatitis GroupOther
Alcoholic hepatitis is defined as having a total bilirubin level >3mg/dL and AST level>50U/L
Heavy Drinking Controls without HepatitisOther
Normal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly
| Study group | Role | What they receive |
|---|---|---|
| With alcoholic hepatitis | HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers with high bilirubin and AST levels. Receives: Other: Alcoholic Hepatitis Group | |
| Without alcoholic hepatitis | HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers without high bilirubin and AST levels. Receives: Other: Heavy Drinking Controls without Hepatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune activation - Levels of sCD14, sCD163
Levels of sCD14, sCD163
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start1 Jul 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir K Gupta, MD, MS, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951662
- Sponsor's protocol ID
- NIAAA 1UH2AA026218
- Status last verified
- Jan 2021
- First submitted
- 14 May 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alcoholic Hepatitis on Immunological and Virological Profiles in HIV-Positive Patients
- ClinicalTrials.gov ID
- NCT03951662
- Acronym / sponsor ID
- NIAAA 1UH2AA026218
- Conditions
- HIV/AIDS, Alcoholic Hepatitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With alcoholic hepatitis | – | Other: Alcoholic Hepatitis GroupHIV-positive patients receiving antiretroviral therapy and who are heavy drinkers with high bilirubin and AST levels. |
| Without alcoholic hepatitis | – | Other: Heavy Drinking Controls without HepatitisHIV-positive patients receiving antiretroviral therapy and who are heavy drinkers without high bilirubin and AST levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients with HIV infection who are receiving antiretroviral therapy and who are heavy drinkers.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcoholic Hepatitis GroupAlcoholic hepatitis is defined as having a total bilirubin level >3mg/dL and AST level>50U/L | Other | With alcoholic hepatitis |
| Heavy Drinking Controls without HepatitisNormal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly | Other | Without alcoholic hepatitis |
Primary outcome
Immune activation - Levels of sCD14, sCD163
Time frame: One year
Levels of sCD14, sCD163
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS and Alcoholic Hepatitis, run by Indiana 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 13 inclusion and 12 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: withdrawn, as of the sponsor's last update on 22 Jan 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Immune activation - Levels of sCD14, sCD163 (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2021.