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New treatment option for Alcohol Use Disorder
Official title Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection
ClinicalTrials.gov ID: NCT06139224
What this study is testing
- What it's testing
- 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 preliminary data support a model in which the combined insult of AUD and HIV on the gut, specifically on the microbiota and intestinal barrier integrity, exacerbates inflammation.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Age 21 to 75 years men and women
- 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 history of zidovudine (AZT) or stavudine (D4T) use.
- No change in ART for at least 6 months.
- CD4+ T cell count of \> 250 cells/µl, nadir CD4+ T cell count of \> 250 cells/µl
You likely can't join if
- Receipt of a non-HIV vaccine within 30 days
- Opportunistic infection within 30 days
- Immunosuppressive medications (e.g., systemic corticosteroids, tacrolimus, sirolimus, mycophenolate, azathioprine, interferon, and cancer...
- History of clinically significant medical disease that could potentially impact the integrity of intestinal barrier function or microbiota including...
- Fiber intake \> 15 grams.
- Chronic HBV and un-treated HCV (documentation of cure can be enrolled)
See the full eligibility criteria
- Age 21 to 75 years men and women
- 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 history of zidovudine (AZT) or stavudine (D4T) use.
- No change in ART for at least 6 months.
- CD4+ T cell count of \> 250 cells/µl, nadir CD4+ T cell count of \> 250 cells/µl
- Plasma HIV-1 RNA level consistently below the limit of detection of commercial ultrasensitive assay (usually \<20 copies/mL) for at least six months before study entry.
- For those for "AUD group" AUDIT-C =/\> 4 for men and = ≥3 for women.
- Documented BMI between 25-40
- Ability and willingness to provide informed consent
- Receipt of a non-HIV vaccine within 30 days
- Opportunistic infection within 30 days
- Immunosuppressive medications (e.g., systemic corticosteroids, tacrolimus, sirolimus, mycophenolate, azathioprine, interferon, and cancer chemotherapy) within 90 days
- History of clinically significant medical disease that could potentially impact the integrity of intestinal barrier function or microbiota including renal (creatinine \>2 mg/dL), liver (documented cirrhosis based on...
- Fiber intake \> 15 grams.
- Chronic HBV and un-treated HCV (documentation of cure can be enrolled)
- Herbal/botanical supplements with potential microbiome or anti-inflammatory effects (e.g., inulin/chicory fiber, berberine, high-dose polyphenols). Participants will be eligible to participant if they discontinue use...
- Regular use of medications that affect intestinal permeability including NSAIDs (daily more than three days a week during the prior two weeks). Type and frequency and duration of NSAID (those taking less than 3 /per...
- Antibiotics (during or prior) four weeks to enrollment. Type and duration of antibiotic treatment within 90 days should be recorded.
- Current use of a restrictive or specialty diet like vegan, vegetarian, gluten-free, Paleo, or any specific carbohydrate diet because these diets can impact the microbiota community.
- Use of herbal, botanical, or nutraceutical supplements with potential effects on the gut microbiome or systemic inflammation. This includes: prebiotic fibers such as inulin, chicory root, fructooligosaccharides (FOS)...
- Gastrointestinal surgeries/resection (cholecystectomy is accepted but should be recorded)
- Currently taking or planning to start a GLP-1 receptor agonist or dual GLP-1/GIP receptor agonist for weight loss or weight management. This includes medications such as semaglutide (Ozempic, Wegovy, Rybelsus)...
- Use of PPI is accepted but type, dose and duration should be recorded.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.