Status:
RECRUITING
Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection
Lead Sponsor:
Rush University Medical Center
Conditions:
Alcohol Use Disorder
Human Immunodeficiency Virus
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Our...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06139224
Start Date
March 5 2024
End Date
August 31 2029
Last Update
June 25 2025
Active Locations (1)
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1
Ali Keshavarzian
Chicago, IL 60612, Illinois, United States, 60612