HIVPhase 2NCT02431325
A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
A Phase 2 study testing Teduglutide in people with HIV, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- Teduglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 21 Jan 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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:
- Hemoglobin > 9.0 g/dL
- Absolute neutrophil count ≥ 1000/mm3
Show all 10Show fewer
- Platelet count ≥ 100,000/mm3
- Prothrombin time (PT) < 1.2 x upper limit of normal (ULN)
- Partial thromboplastin time (PTT) < 1.5 x ULN
- 4. Ability and willingness to give written informed consent and to comply with study requirements
Who cannot join
- 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
- 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.
- Use of any immunomodulatory agents within 30 days prior to study enrollment
- History of intolerance, sensitivity, allergy or anaphylaxis to benzodiazepines or other narcotics to be used during the colonoscopy or upper endoscopy procedure
Show all 26Show fewer
- 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.
- Patients with previous allergic reactions to iodine-containing contrast media
- Renal disease or creatinine >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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Study to Investigate Gastrointestinal Epithelial Integrity and Arterial Inflammation in Individuals With and Without HIV
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.
Read the detailed description
As more people with HIV gain access to combination antiretroviral therapy (cART), cardiovascular disease has become increasingly prevalent and a significant cause of mortality. 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. Translocation of microbial products from the intestinal lumen into the systemic circulation has been demonstrated to be increased in HIV-infected patients and the investigators hypothesize that it is a key driver of monocyte and macrophage activation. In turn, these pro-inflammatory monocytes and macrophages can induce atherosclerotic disease development. The purpose of the research study is to determine the effects of a glucagon-like peptide-2 analog, teduglutide, on intestinal epithelial integrity, microbial translocation across the gut lumen, markers of innate immune system activation including the monocyte transcriptome, bone, arterial inflammation, and atherosclerosis in a 6-month randomized, double-blind placebo-controlled proof of concept trial in HIV-infected individuals.
- Conditions
- HIV
- Being tested
- Teduglutide, Placebo
- Keywords
- HIV, Atherosclerosis, Microbial Translocation, Teduglutide, Gastrointestinal Permeability, Inflammation
- Medical subject headings
- Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeduglutideDrug
Also called Gattex
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Teduglutide | Experimental | Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration Receives: Drug: Teduglutide |
| Placebo | Placebo comparator | Placebo, subcutaneous injection, 6 months duration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake
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 ratio of the activity in the vessel wall divided by the blood background). The most diseased segment is the approximately 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the change in the mean value, of the TBR, from baseline to 6 months.
Measured: Change from baseline at 6 months
Change in Intestinal Epithelial Integrity
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.
Measured: Change from baseline at 6 months
Change in Soluble CD14 Concentration
Soluble CD14 is a marker of monocyte activation. An increase in soluble CD14 concentration indicates an increase in inflammation.
Measured: Change from baseline at 6 months
Secondary outcomes (17)
Change in Intestinal CD4+ T-cells
Change in CD161+CCR6+ (Th17) cells as a percentage of CD4+ T-cells in the duodenum. An increase in Th17 cells indicates a beneficial restoration of this CD4+ T-cell population in the small intestine, which are pathologically depleted in people with HIV.
Measured: Change from baseline at 6 months
Change in CD14+CD86+CD40+ Monocytes
Change in pro-inflammatory monocytes. A positive change indicates increased inflammation.
Measured: Change from baseline at 6 months
Change in HLA-DR+CD38+ CD8+ T Cells
Change in activated CD8+ T Cells. A positive change indicates increased inflammation.
Measured: Change from baseline at 6 months
Change in HLA-DR+CD38+ CD4+ T Cells
Change in activated CD4+ T Cells. A positive change indicates increased inflammation.
Measured: Change from baseline at 6 months
Change in Soluble CD163 Concentration
An increase in soluble CD163 concentration indicates an increase in inflammation.
Measured: Change from baseline at 6 months
Change in Intestinal Fatty Acid Binding Protein Concentration
An increase in I-FABP indicates an increase in intestinal mucosal damage.
Measured: Change from baseline at 6 months
Change in Plasma Riboflavin Concentration
Change in plasma riboflavin is calculated as log2 of the ratio of plasma riboflavin at study end to baseline. A positive number indicates an increase in riboflavin levels.
Measured: Change from baseline at 6 months
Change in Bone Mineral Density
Change in femoral neck bone mineral density. An increase in bone mineral density is beneficial for bone health.
Measured: Change from baseline at 6 months
Change in Plaque Volume on Cardiac Computed Tomography Angiography
Noncalcified plaque volume. Increased noncalcified plaque volume may indicate increased atherosclerosis.
Measured: Change from baseline at 6 months
Change in Hemoglobin A1c Percentage
A higher hemoglobin A1c percentage indicates a higher blood glucose level over a 3 month average.
Measured: Change from baseline at 6 months
Change in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)
A higher HOMA-IR indicates greater insulin resistance. Values greater than 2 suggests insulin resistance. HOMA-IR was calculated using a formula based on Matthews et al. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985;28(7):412-419.
Measured: Change from baseline at 6 months
Change in Visceral Adipose Tissue (VAT) Area
Abdominal VAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra. VAT is considered metabolically unhealthy fat.
Measured: Change from baseline at 6 months
Change in Subcutaneous Adipose Tissue (SAT) Area
Abdominal SAT area was measured using single-slice abdominal CT at the level of the fourth lumbar vertebra.
Measured: Change from baseline at 6 months
Change in Body Mass Index (BMI)
BMI is a measure of adiposity.
Measured: Change from baseline at 6 months
Change in Depressive Symptoms
Change in the Center for Epidemiological Studies-Depression (CES-D) score. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Measured: Change from baseline at week 12 and at week 24
Change in Cognitive Performance, Defined as a Global Neurocognitive Z-score
The Global Neurocognitive Z-Score is calculated as an average of the z-scores from the following neurocognitive assessments: Hopkins Verbal Learning Test (HVLT) Total Recall, HVLT Delayed Recall, HVLT Retention, HVLT Recognition, Wechsler Adult Intelligence Scale (WAIS) Digit Span Forward, WAIS Digit Span Backward, WAIS Digit Span Sequence, Stroop Word, Stroop Color, Stroop Color Word, Stroop Interference, Grooved Pegboard Dominant, and Grooved Pegboard Nondominant. A z-score of 0 corresponds with the population mean, and a positive z-score indicates better neurocognitive function than the population mean. A positive change indicates an improvement in neurocognitive function, and a negative change indicates a detriment to performance over time.
Measured: Change from baseline at week 24
Change in Domain-specific Cognitive Performance, Defined as a Domain-specific Neurocognitive Z-score
Change in motor-specific performance z-score. A z-score of 0 corresponds with the population mean, and a positive z-score indicates better motor-specific performance than the population mean. A positive change indicates an improvement in motor-specific performance, and a negative change indicates a detriment to performance over time.
Measured: Change from baseline at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startDec 2015
- Primary completion21 Jan 2020
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ragon Institute of MGH, MIT and Harvard, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Janet Lo, MD, Massachusetts General Hospital
- Investigators
- Janet Lo, MD, MMSc, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431325
- Sponsor's protocol ID
- 2013P002669
- Other IDs
- 1R01HL123351-01
- Status last verified
- May 2023
- First submitted
- 23 Feb 2015
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate Gastrointestinal Epithelial Integrity and Arterial Inflammation in Individuals With and Without HIV
- ClinicalTrials.gov ID
- NCT02431325
- Acronym / sponsor ID
- 2013P002669
- Conditions
- HIV
- Keywords
- HIV, Atherosclerosis, Microbial Translocation, Teduglutide, Gastrointestinal Permeability, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Ragon Institute of MGH, MIT and Harvard, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Study start
- Dec 2015
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 1 May 2015 (estimated)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As more people with HIV gain access to combination antiretroviral therapy (cART), cardiovascular disease has become increasingly prevalent and a significant cause of mortality. 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. Translocation of microbial products from the intestinal lumen into the systemic circulation has been demonstrated to be increased in HIV-infected patients and the investigators hypothesize that it is a key driver of monocyte and macrophage activation. In turn, these pro-inflammatory monocytes and macrophages can induce atherosclerotic disease development. The purpose of the research study is to determine the effects of a glucagon-like peptide-2 analog, teduglutide, on intestinal epithelial integrity, microbial translocation across the gut lumen, markers of innate immune system activation including the monocyte transcriptome, bone, arterial inflammation, and atherosclerosis in a 6-month randomized, double-blind placebo-controlled proof of concept trial in HIV-infected individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teduglutide | Experimental | Drug: TeduglutideTeduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, subcutaneous injection, 6 months duration |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 4. Ability and willingness to give written informed consent and to comply with study requirements
Key exclusion criteria (26 listed)
- 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
- 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.
- Use of any immunomodulatory agents within 30 days prior to study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeduglutideAlso: Gattex | Drug | Teduglutide |
| Placebo | Drug | Placebo |
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 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 ratio of the activity in the vessel wall divided by the blood background). The most diseased segment is the approximately 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the change in the mean value, of the TBR, from baseline to 6 months.
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.
17 secondary outcomes
Change in Intestinal CD4+ T-cells
Time frame: Change from baseline at 6 months
Change in CD14+CD86+CD40+ Monocytes
Time frame: Change from baseline at 6 months
Change in HLA-DR+CD38+ CD8+ T Cells
Time frame: Change from baseline at 6 months
Change in HLA-DR+CD38+ CD4+ T Cells
Time frame: Change from baseline at 6 months
Change in Soluble CD163 Concentration
Time frame: Change from baseline at 6 months
Change in Intestinal Fatty Acid Binding Protein Concentration
Time frame: Change from baseline at 6 months
Change in Plasma Riboflavin Concentration
Time frame: Change from baseline at 6 months
Change in Bone Mineral Density
Time frame: Change from baseline at 6 months
Change in Plaque Volume on Cardiac Computed Tomography Angiography
Time frame: Change from baseline at 6 months
Change in Hemoglobin A1c Percentage
Time frame: Change from baseline at 6 months
Change in Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)
Time frame: Change from baseline at 6 months
Change in Visceral Adipose Tissue (VAT) Area
Time frame: Change from baseline at 6 months
Change in Subcutaneous Adipose Tissue (SAT) Area
Time frame: Change from baseline at 6 months
Change in Body Mass Index (BMI)
Time frame: Change from baseline at 6 months
Change in Depressive Symptoms
Time frame: Change from baseline at week 12 and at week 24
Change in Cognitive Performance, Defined as a Global Neurocognitive Z-score
Time frame: Change from baseline at week 24
Change in Domain-specific Cognitive Performance, Defined as a Domain-specific Neurocognitive Z-score
Time frame: Change from baseline at week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Lo, MD, MMSc principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teduglutide in people with HIV, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake (time frame: Change from baseline at 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.