A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
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.
Timeline
- Start
- 2015-12
- Primary completion
- 2020-01-21
- Completion
- 2021-01-21
Outcome
Mixed primary results
registry MEAN Teduglutide: -0.28 (Standard Deviation 0.29) ratio NCT02431325 ↗
registry MEAN Placebo: 0.01 (Standard Deviation 0.35) ratio NCT02431325 ↗
registry analysis (superiority test); Teduglutide vs Placebo; p = 0.01; ANCOVA NCT02431325 ↗
registry MEAN Teduglutide: 0.39 (Standard Deviation 0.67) log2 ratio NCT02431325 ↗
registry MEAN Placebo: -0.10 (Standard Deviation 0.22) log2 ratio NCT02431325 ↗
registry analysis (superiority test); Teduglutide vs Placebo; p = 0.04; t-test, 2 sided NCT02431325 ↗
registry MEAN Teduglutide: 117.70 (Standard Deviation 387.56) ng/mL NCT02431325 ↗
registry MEAN Placebo: 142.85 (Standard Deviation 242.01) ng/mL NCT02431325 ↗
registry analysis (superiority test); Teduglutide vs Placebo; p = 0.87; t-test, 2 sided NCT02431325 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Teduglutide | Peptide | 0.05 mg/kg | Subcutaneous |