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

What Was Tested

In this phase 2 trial, researchers set out to test Teduglutide (GLP-2 analog).

HIV disease is linked to inflammatory changes and leakiness of the gut.

It had two arms (groups): Teduglutide (experimental) and Placebo (placebo comparator).

Placebo, subcutaneous injection, 6 months duration.

The registry classes the interventions as drug.

More on the Plan

Activation of the innate immune system may stimulate inflammatory mechanisms of atherosclerosis development.

Loss of gastrointestinal (GI) mucosal epithelial integrity and loss of CD4+ T-lymphocytes in the intestinal lamina propria occur in HIV-infected patients and are not fully restored by cART.

In turn, these pro-inflammatory monocytes and macrophages can induce atherosclerotic disease development.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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:. Absolute neutrophil count ≥ 1000/mm3.

The full record lists 9 inclusion and 26 exclusion criteria; among the exclusions: first-degree relative with history of colon cancer; active gall bladder, biliary or pancreatic disease; female subject who is pregnant, nursing or less than 8 weeks post partum.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Teduglutide (GLP-2 analog) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Teduglutide (GLP-2 analog) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-12 with completion listed for 2020-01-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake (time frame: Change from baseline at 6 months). Change in Intestinal Epithelial Integrity (time frame: Change from baseline at 6 months). Change in Soluble CD14 Concentration (time frame: Change from baseline at 6 months).

It also tracked 17 secondary outcomes, for example Change in Intestinal CD4+ T-cells, Change in CD14+CD86+CD40+ Monocytes, Change in HLA-DR+CD38+ CD8+ T Cells, Change in HLA-DR+CD38+ CD4+ T Cells, Change in Soluble CD163 Concentration and Change in Intestinal Fatty Acid Binding Protein Concentration.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teduglutide (GLP-2 analog) in 32 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.