| Condition or disease | Intervention/treatment | 
|---|---|
| HIV/AIDS Alcoholic Hepatitis | Other: Alcoholic Hepatitis Group Other: Heavy Drinking Controls without Hepatitis | 
| Study Type : | Observational | 
| Actual Enrollment : | 0 participants | 
| Observational Model: | Case-Control | 
| Time Perspective: | Prospective | 
| Official Title: | Effects of Alcoholic Hepatitis on Immunological and Virological Profiles in HIV-Positive Patients | 
| Actual Study Start Date : | July 1, 2020 | 
| Actual Primary Completion Date : | September 30, 2020 | 
| Actual Study Completion Date : | September 30, 2020 | 
| 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 
 | 
              
| 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 | 
Inclusion Criteria:
For Group 1 (Alcoholic Hepatitis Group), the presence of alcoholic hepatitis is defined by
For Group 2 (Heavy drinking controls without hepatitis):
Exclusion Criteria:
| United States, Indiana | |
| Infectious Diseases Research Center | |
| Indianapolis, Indiana, United States, 46202 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 14, 2019 | ||||
| First Posted Date | May 15, 2019 | ||||
| Last Update Posted Date | January 22, 2021 | ||||
| Actual Study Start Date | July 1, 2020 | ||||
| Actual Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures  | 
            Immune activation - Levels of sCD14, sCD163 [ Time Frame: One year ] Levels of sCD14, sCD163 
             | 
    ||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Immunology of HIV and Alcoholic Hepatitis | ||||
| Official Title | Effects of Alcoholic Hepatitis on Immunological and Virological Profiles in HIV-Positive Patients | ||||
| 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. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective  | 
    ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention:   Samples Without DNA Description: 
PBMC, plasma, serum 
             | 
    ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 40 patients with HIV infection who are receiving antiretroviral therapy and who are heavy drinkers. | ||||
| Condition | 
  | 
    ||||
| Intervention | 
  | 
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| Study Groups/Cohorts | 
  | 
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| Publications * | Not Provided | ||||
| 
         * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.  | 
    |||||
| Recruitment Information | |||||
| Recruitment Status | Withdrawn | ||||
| Actual Enrollment  | 
            0 | ||||
| Original Estimated Enrollment  | 
            40 | ||||
| Actual Study Completion Date | September 30, 2020 | ||||
| Actual Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | 
 Inclusion Criteria: 
 Exclusion Criteria: 
  | 
    ||||
| Sex/Gender | 
  | 
    ||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03951662 | ||||
| Other Study ID Numbers | NIAAA 1UH2AA026218 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product | 
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| IPD Sharing Statement | 
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| Responsible Party | Samir K Gupta, MD, MS, Indiana University | ||||
| Study Sponsor | Indiana University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Indiana University | ||||
| Verification Date | January 2021 | ||||