A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV

Description

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.

Study Start Date

December 2015

Estimated Completion Date

June 2019

Interventions

  • Drug: Teduglutide
  • Drug: Placebo

Specialties

  • Cardiology: Vascular Medicine
  • Infectious Disease: HIV/Immunodeficiency
  • Physician Assistant: Infectious Disease

MeSH Terms

  • Inflammation
  • Teduglutide

Study ID

Massachusetts General Hospital -- 2013P002669

Status

Unknown

Trial ID

NCT02431325

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

60

Sponsor

Massachusetts General Hospital

Inclusion Criteria

    1. Men and women age 21-60 with previously diagnosed HIV disease 2. Stable anti-retroviral therapy (ART) as defined by no changes in ART regimen for >6 months 3. To be eligible for colonoscopy procedure, laboratory values that meet the following criteria: 1. Hemoglobin > 9.0 g/dL 2. Absolute neutrophil count ? 1000/mm3 3. Platelet count ? 100,000/mm3 4. Prothrombin time (PT) < 1.2 x upper limit of normal (ULN) 5. Partial thromboplastin time (PTT) < 1.5 x ULN 4. Ability and willingness to give written informed consent and to comply with study requirements

Exclusion Criteria

    1. 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 2. Active gall bladder, biliary or pancreatic disease 3. Female subject who is pregnant, nursing or less than 8 weeks post partum. 4. Use of any immunomodulatory agents within 30 days prior to study enrollment 5. History of intolerance, sensitivity, allergy or anaphylaxis to benzodiazepines or other narcotics to be used during the colonoscopy procedure 6. 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. 7. Patients with previous allergic reactions to iodine-containing contrast media 8. Renal disease or creatinine >1.5 mg/dL (contrast will be administered during CT angiography of the heart) 9. History of requiring antibiotic prophylaxis for invasive procedures 10. History of myocardial infarction, decompensated cirrhosis, or any other condition that in the opinion of the investigator will compromise ability to participate in the study 11. Currently taking anticoagulants including but not limited to: heparin (Hep-Lock, Hep-Pak), Hep-Pak CVC, Heparin Lock Flush), warfarin (Coumadin), tinzaparin (Innohep), enoxaparin (Lovenox), danaparoid (Orgaran), dalteparin (Fragmin), clopidogrel (Plavix), prophylactic aspirin, and regular NSAID use 12. Subject taking any of the following medications: statins, systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g. local injection of interferon alpha for treatment of HPV is permitted), systemic chemotherapy including oral chemotherapeutic agents, methotrexate, octreotide, growth hormone, antiarrhythmics including digoxin, antiepileptics, immunosuppressants, vancomycin, rifampin, aminoglycosides, clonidine, prazosin, lithium and ritonavir-boosted lopinavir (Kaletra). 13. Subject has had two or more endoscopy procedures (sigmoidoscopy, upper endoscopy or colonoscopy) within the past 12 months for clinical purposes or other research studies. 14. Body weight greater than 300 lbs due to CT scanner table limitations 15. Active illicit drug use 16. Patients who report any significant radiation exposure over the course of the year prior to randomization. Significant exposure is defined as: 1. More than 2 percutaneous coronary interventions (PCI) within 12 months of randomization 2. More than 2 myocardial perfusion studies within the past 12 months 3. More than 2 CT angiograms within the past 12 months 4. Any subjects with history of radiation therapy 17. Patients already scheduled or being considered for a procedure or treatment requiring significant radiation exposure (e.g., radiation therapy, PCI, or catheter ablation of arrhythmia) within 12 months of randomization 18. History of malignancy

Gender

Both

Ages

21 Years to 60 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Janet Lo MD MMSc 617-724-3425 JLo@partners.org

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