NCT02431325

A Study to Investigate Gastrointestinal Epithelial Integrity and Arterial Inflammation in Individuals With and Without HIV

Completed Phase 2 Results posted Last updated 17 May 2023

What this trial tests

Phase 2 trial testing Teduglutide in HIV in 32 participants. Completed in 21 January 2021.

Timeline

1 December 2015

Primary endpoint
21 January 2020

21 January 2021

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	32
Start date	1 December 2015
Primary completion	21 January 2020
Estimated completion	21 January 2021
Sites	1 location across United States

Drugs / interventions tested

• Teduglutide (TEDUGLUTIDE) — full drug profile →
• Placebo

Conditions studied

• HIV — all drugs for HIV →

Sponsor

Massachusetts General Hospital

Who can join

Adults 21 to 65, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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 maximum target to background ratio (TBRmax) of the most diseased segment (MDS) of the carotid index vessel. A negative number for the change in TBR implies a reduction in activity over time, which is considered an improvement in carotid arterial inflammation. Arterial FDG Uptake provides a measure of inflammation in the artery wall. TBR is target-to-background ratio (a measure of the rat
• Change in Intestinal Epithelial Integrity
  Time frame: Change from baseline at 6 months
  Change in plasma citrulline is calculated as log2 of the ratio of plasma citrulline at study end to baseline. Citrulline is a measure of functional small bowel mass, so a positive number is considered an improvement in intestinal epithelial integrity.
• Change in Soluble CD14 Concentration
  Time frame: Change from baseline at 6 months
  Soluble CD14 is a marker of monocyte activation. An increase in soluble CD14 concentration indicates an increase in inflammation.

Sponsor's own 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inflammation, immune activation, and cardiovascular disease in HIV.
   Nou E, Lo J, Grinspoon SK. · · 2016 · cited 181× · PMID 27058351 · DOI 10.1097/qad.0000000000001109
2. Coronary Artery Disease in HIV-Infected Patients: Downside of Living Longer.
   Lacson JC, Barnes RP, Bahrami H. · · 2017 · cited 29× · PMID 28265887 · DOI 10.1007/s11883-017-0651-4
3. Alcohol Use and Abuse Conspires With HIV Infection to Aggravate Intestinal Dysbiosis and Increase Microbial Translocation in People Living With HIV: A Review.
   Yan J, Ouyang J, Isnard S, Zhou X, et al · · 2021 · cited 11× · PMID 34975838 · DOI 10.3389/fimmu.2021.741658
4. HIV and the gut: implications for HIV persistence, immune dysfunction and cure strategies.
   Lau JSY, Lewin SR, Telwatte S. · · 2025 · cited 3× · PMID 41050701 · DOI 10.3389/fimmu.2025.1650852