| 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
|
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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 | ||||