EFFECTS OF ALCOHOLIC HEPATITIS ON IMMUNOLOGICAL AND VIROLOGICAL PROFILES IN HIV-POSITIVE PATIENTS.

Overview

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 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.

Description

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: HIV-POSITIVE.
  • Age: Between 21 Years - 100 Years
  • Gender: Male or Female

Inclusion:

Age equal to or greater than 21 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
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.

 

Exclusion:

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)
Fever, defined as T ≥ 38.0 C 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)

Updated on 20 Nov 2022 . Study ID: NCT0395166

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