Phase 2 N=32 Randomized Quadruple-blind Treatment

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

HIV

Bottom Line

View on ClinicalTrials.gov: NCT02431325 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake — -0.28; 0.01 ratio — p=0.01

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Teduglutide (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake	-0.28; 0.01	0.01 sig
PRIMARY Change in Intestinal Epithelial Integrity	0.39; -0.10	0.04 sig
PRIMARY Change in Soluble CD14 Concentration	117.70; 142.85	0.87
SECONDARY Change in Intestinal CD4+ T-cells	13.17; -4.81	0.047 sig
SECONDARY Change in CD14+CD86+CD40+ Monocytes	-19.24; -3.31	<0.05 sig
SECONDARY Change in HLA-DR+CD38+ CD8+ T Cells	-0.33; 0.67	0.07
SECONDARY Change in HLA-DR+CD38+ CD4+ T Cells	0.0013; 0.058	0.68
SECONDARY Change in Soluble CD163 Concentration	-9.26; 22.77	0.49
SECONDARY Change in Intestinal Fatty Acid Binding Protein Concentration	-270.04; -215.27	1.00
SECONDARY Change in Plasma Riboflavin Concentration	0.55; -0.36	0.04 sig
SECONDARY Change in Bone Mineral Density	0.015; -0.0078	0.07
SECONDARY Change in Plaque Volume on Cardiac Computed Tomography Angiography	-0.74; 0.00	1.00
SECONDARY Change in Hemoglobin A1c Percentage	-0.1; -0.1	0.34
SECONDARY Change in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)	-0.40; 1.13	0.33
SECONDARY Change in Visceral Adipose Tissue (VAT) Area	-12.09; -7.94	0.84
SECONDARY Change in Subcutaneous Adipose Tissue (SAT) Area	-9.71; -0.11	0.51
SECONDARY Change in Body Mass Index (BMI)	-0.33; -0.27	0.93
SECONDARY Change in Depressive Symptoms	1; -3; 0; 3	0.09
SECONDARY Change in Cognitive Performance, Defined as a Global Neurocognitive Z-score	0.23; -0.04	0.51
SECONDARY Change in Domain-specific Cognitive Performance, Defined as a Domain-specific Neurocognitive Z-score	1.73; -0.52	0.07

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.

Eligibility Criteria

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 9.0 g/dL
Absolute neutrophil count ≥ 1000/mm3
Platelet count ≥ 100,000/mm3
Prothrombin time (PT) 1.5 mg/dL (contrast will be administered during CT angiography of the heart)
History of requiring antibiotic prophylaxis for invasive procedures
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
Currently taking anticoagulants including but not limited to: heparin, warfarin (Coumadin), tinzaparin (Innohep), enoxaparin (Lovenox), danaparoid (Orgaran), dalteparin (Fragmin), clopidogrel (Plavix), prophylactic aspirin, and regular NSAID use
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 human papilloma virus 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).
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.
Body weight greater than 300 lbs due to CT scanner table limitations
Active illicit drug use
Patients who report any significant radiation exposure over the course of the year prior to randomization. Significant exposure is defined as:
More than 2 percutaneous coronary interventions (PCI) within 12 months of randomization
More than 2 myocardial perfusion studies within the past 12 months
More than 2 CT angiograms within the past 12 months
Any subjects with history of radiation therapy
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
History of malignancy
Prior recipient of a HIV vaccine

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02431325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.