NCT03951662

Immunology of HIV and Alcoholic Hepatitis

Effects of Alcoholic Hepatitis on Immunological and Virological Profiles in HIV-Positive Patients

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV/AIDS
• Alcoholic Hepatitis

Interventions

Type	Name	Description
OTHER	Alcoholic Hepatitis Group	Alcoholic hepatitis is defined as having a total bilirubin level \>3mg/dL and AST level\>50U/L
OTHER	Heavy Drinking Controls without Hepatitis	Normal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2019-05-15
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States