Condition or disease | Intervention/treatment |
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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 |
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With alcoholic hepatitis
HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers with high bilirubin and AST levels.
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Other: Alcoholic Hepatitis Group
Alcoholic hepatitis is defined as having a total bilirubin level >3mg/dL and AST level>50U/L
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Without alcoholic hepatitis
HIV-positive patients receiving antiretroviral therapy and who are heavy drinkers without high bilirubin and AST levels.
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Other: Heavy Drinking Controls without Hepatitis
Normal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly
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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 | |||||
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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
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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 |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description:
PBMC, plasma, serum
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Sampling Method | Non-Probability Sample | ||||
Study Population | 40 patients with HIV infection who are receiving antiretroviral therapy and who are heavy drinkers. | ||||
Condition |
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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. |
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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:
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Sex/Gender |
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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 |