A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV (NCT02431325) | Clinical Trial Compass
CompletedPhase 2
A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
United States32 participantsStarted 2015-12
Plain-language summary
The purpose of this research study is to determine whether teduglutide can repair a "leaky" gut, decrease inflammation, and prevent or treat plaque, a build-up of fat and other materials in the blood vessels of the heart, in people with HIV. HIV disease is linked to inflammatory changes and leakiness of the gut. These changes or conditions may increase the risk of developing heart and blood vessel disease. The investigators believe teduglutide can help repair the gut barrier in people with HIV, leading to a decrease in inflammation and plaque in the blood vessels of the heart.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. Men and women age 21-65 with previously diagnosed HIV disease
✓. Stable anti-retroviral therapy (ART) as defined by no changes in ART regimen for \>6 months
✓. HIV viral load \< 200 copies/mL
✓. To be eligible for colonoscopy procedure, laboratory values that meet the following criteria:
✓. Hemoglobin \> 9.0 g/dL
✓. Absolute neutrophil count ≥ 1000/mm3
✓. Platelet count ≥ 100,000/mm3
✓. Prothrombin time (PT) \< 1.2 x upper limit of normal (ULN)
Exclusion criteria
✕. History of clinically significant gastrointestinal disease including but not limited to: colon cancer, intestinal obstruction, ulcerative colitis, Crohn's disease, or history of C. difficile within the past 3 months
✕. First-degree relative with history of colon cancer
What they're measuring
1
Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake
✕. Active gall bladder, biliary or pancreatic disease
✕. Female subject who is pregnant, nursing or less than 8 weeks post partum.
✕. Use of any immunomodulatory agents within 30 days prior to study enrollment
✕. History of intolerance, sensitivity, allergy or anaphylaxis to benzodiazepines or other narcotics to be used during the colonoscopy or upper endoscopy procedure
✕. Contraindication to beta-blocker (including moderate to severe asthma or heart block) or nitroglycerin use as these drugs are given as part of the standard cardiac CT protocol. Previous allergic reaction to beta blocker or nitroglycerin.
✕. Patients with previous allergic reactions to iodine-containing contrast media