Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection

Launched by RUSH UNIVERSITY MEDICAL CENTER · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how alcohol use disorder (AUD) might affect inflammation in people living with HIV, even when they are receiving treatment. The study aims to understand if changes in the gut bacteria and the health of the intestines caused by alcohol can worsen inflammation and other health issues in those with HIV. Researchers believe that a type of supplement called short-chain fatty acid prebiotics may help protect the intestines from damage caused by alcohol and reduce inflammation.

To participate in this study, individuals must be between 45 and 80 years old and either living with HIV and on treatment for at least a year or HIV-negative. Participants will attend two visits where they will provide stool and blood samples, answer questionnaires, and undergo tests to assess their gut health and inflammation levels. This trial is important as it could lead to new ways to improve health for people living with HIV, especially those who struggle with alcohol use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * HIV+ Group :
• • Age 45 to 80 years
• • Infection with HIV-1, as documented by a licensed ELISA and confirmed by a Western blot or HIV-1 RNA
• • On ART for at least 12 months
• • No change in ART for at least three months
• • CD4+ T cell count of 350 cells/µl
• • Plasma HIV-1 RNA level consistently below the limit of detection of commercial ultrasensitive assays for at least six months before study entry.
• • Ability and willingness to provide informed consent
• * HIV Negative Group:
• • Age 45 to 80 years
• • Matched to the HIV+ ART-treated group (age (+/- 5 years), gender, ethnicity, sexual orientation, smoking, and body mass index (+/-3)).
• • Ability and willingness to provide informed consent
• Exclusion criteria:
• * Any condition that, in the opinion of the gastrointestinal (GI) specialist, would either be a contraindication to endoscopy or would increase the risk from sedation, endoscopy, or mucosal biopsies. These conditions may include, but are not limited to:
• • Significant complication (such as perforation) from prior endoscopy
• • Known bleeding diathesis
• • Platelet count \< 100,000 per µl
• • INR \> 1.3
• • Current use of antiplatelet agents (aspirin, other NSAIDs, clopidogrel (PlavixÒ), other antiplatelet agents) or anticoagulants (heparin, low molecular weight heparin, warfarin, lepirudin, or other anticoagulants) and inability to temporarily hold such medications for endoscopy.
• • Decompensated disease (e.g., active angina, unstable angina, or MI within two months, congestive heart failure, renal failure and dialysis, respiratory insufficiency with FEV1 \< 1L or oxygen dependence, cirrhosis, uncontrolled diabetes)
• • Ongoing substance abuse
• • Receipt of a non-HIV vaccine within 30 days
• • Opportunistic infection within 60 days
• • Immunosuppressive medications (e.g., systemic corticosteroids, tacrolimus, sirolimus, mycophenolate, azathioprine, interferon, and cancer chemotherapy) within 60 days
• • Alcoholism including binging
• • history of clinically significant medical disease, includes renal (creatinine \>2 mg/dL), liver (documented cirrhosis based on histology or ALT/AST greater than 2 1/2 times normal), cardiac failure (NY classification III/IV), or uncontrolled diabetes (Hgb- A1c\>8%).
• • Regular use of NSAIDs (daily more than three days a week during the prior two weeks of starting the study)
• • Antibiotic use during prior four weeks to the colonoscopy).
• • Abnormal blood clotting time (e.g., prolonged PT) or use of anticoagulant during 3-7 days prior to colonoscopy that would preclude biopsy sample collection.
• • Obesity (BMI\>30 because it can affect the microbiota community.
• • Use of special diet like vegan, vegetarian, gluten-free, Paleo, specific carbohydrate diet because these diets can impact the microbiota community.
• • Inflammatory bowel disease.
• • Celiac disease.
• • GI cancers
• • gastrointestinal surgeries/resection
• • Inability to sign an informed consent form.