Trial · NCT02431325

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

NCT02431325, Phase 2, Completed, Massachusetts General Hospital; results first posted 2023-06-12

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV. Trials, record NCT02431325. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02431325

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
NCT number: NCT02431325
Status: Completed
Phases: Phase 2
Enrollment: 32 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: HIV
Interventions: Teduglutide, Placebo
First posted: 2015-05-01
Last updated: 2023-06-12
Results first posted: 2023-06-12

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake	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.
Primary	Change in Intestinal Epithelial Integrity	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.
Primary	Change in Soluble CD14 Concentration	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.
Secondary	Change in Intestinal CD4+ T-cells	Change from baseline at 6 months	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.
Secondary	Change in CD14+CD86+CD40+ Monocytes	Change from baseline at 6 months	Change in pro-inflammatory monocytes. A positive change indicates increased inflammation.
Secondary	Change in HLA-DR+CD38+ CD8+ T Cells	Change from baseline at 6 months	Change in activated CD8+ T Cells. A positive change indicates increased inflammation.
Secondary	Change in HLA-DR+CD38+ CD4+ T Cells	Change from baseline at 6 months	Change in activated CD4+ T Cells. A positive change indicates increased inflammation.
Secondary	Change in Soluble CD163 Concentration	Change from baseline at 6 months	An increase in soluble CD163 concentration indicates an increase in inflammation.
Secondary	Change in Intestinal Fatty Acid Binding Protein Concentration	Change from baseline at 6 months	An increase in I-FABP indicates an increase in intestinal mucosal damage.
Secondary	Change in Plasma Riboflavin Concentration	Change from baseline at 6 months	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.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake	Change from baseline at 6 months	The subset of participants with interpretable FDG-PET scans at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.	ratio	MEAN
PRIMARY	Change in Intestinal Epithelial Integrity	Change from baseline at 6 months	The subset of participants with available metabolite assessments at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.	log2 ratio	MEAN
PRIMARY	Change in Soluble CD14 Concentration	Change from baseline at 6 months	The subset of participants with soluble CD14 available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.	ng/mL	MEAN
SECONDARY	Change in Intestinal CD4+ T-cells	Change from baseline at 6 months	The subset of participants with available biopsy samples from endoscopies at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.	percentage of CD4+ T-cells	MEAN
SECONDARY	Change in CD14+CD86+CD40+ Monocytes	Change from baseline at 6 months	The subset of participants with peripheral blood flow cytometry data available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention. Two participants in the placebo group did not have interpretable data for this monocyte population.	percentage of CD14+ monocytes	MEAN
SECONDARY	Change in HLA-DR+CD38+ CD8+ T Cells	Change from baseline at 6 months	The subset of participants with peripheral blood flow cytometry at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.	percentage of T Cells	MEAN
SECONDARY	Change in HLA-DR+CD38+ CD4+ T Cells	Change from baseline at 6 months	The subset of participants with peripheral blood flow cytometry at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.	percentage of T Cells	MEAN
SECONDARY	Change in Soluble CD163 Concentration	Change from baseline at 6 months	The subset of participants with soluble CD163 data available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.	ng/mL	MEAN
SECONDARY	Change in Intestinal Fatty Acid Binding Protein Concentration	Change from baseline at 6 months	The subset of participants with I-FABP data available at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.	pg/mL	MEDIAN
SECONDARY	Change in Plasma Riboflavin Concentration	Change from baseline at 6 months	The subset of participants with metabolite assessments at baseline and study end, excluding one participant in the placebo group that discontinued ART during the intervention.	log2 ratio	MEAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake	Teduglutide	-0.28	Standard Deviation 0.29	ratio
Change in Arterial Target to Background Ratio of 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Uptake	Placebo	0.01	Standard Deviation 0.35	ratio
Change in Intestinal Epithelial Integrity	Teduglutide	0.39	Standard Deviation 0.67	log2 ratio
Change in Intestinal Epithelial Integrity	Placebo	-0.10	Standard Deviation 0.22	log2 ratio
Change in Soluble CD14 Concentration	Teduglutide	117.70	Standard Deviation 387.56	ng/mL
Change in Soluble CD14 Concentration	Placebo	142.85	Standard Deviation 242.01	ng/mL
Change in Intestinal CD4+ T-cells	Teduglutide	13.17	Standard Deviation 18.15	percentage of CD4+ T-cells
Change in Intestinal CD4+ T-cells	Placebo	-4.81	Standard Deviation 15.98	percentage of CD4+ T-cells
Change in CD14+CD86+CD40+ Monocytes	Teduglutide	-19.24	Standard Deviation 14.12	percentage of CD14+ monocytes
Change in CD14+CD86+CD40+ Monocytes	Placebo	-3.31	Standard Deviation 13.97	percentage of CD14+ monocytes

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Teduglutide	17
Overall Study	STARTED	Placebo	15
Overall Study	COMPLETED	Teduglutide	9
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	Teduglutide	8
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal or epigastric pain, discomfort, cramping	Gastrointestinal disorders	Teduglutide	5	17
other	Abdominal or epigastric pain, discomfort, cramping	Gastrointestinal disorders	Placebo	3	15
other	Burping, gas	Gastrointestinal disorders	Teduglutide	3	17
other	Burping, gas	Gastrointestinal disorders	Placebo	1	15
other	Bloating	Gastrointestinal disorders	Teduglutide	6	17
other	Bloating	Gastrointestinal disorders	Placebo	3	15
other	Constipation	Gastrointestinal disorders	Teduglutide	4	17
other	Constipation	Gastrointestinal disorders	Placebo	2	15
other	Loose stool, diarrhea	Gastrointestinal disorders	Teduglutide	2	17
other	Loose stool, diarrhea	Gastrointestinal disorders	Placebo	4	15

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Teduglutide	0	17
Total, all-cause mortality	Placebo	0	15
Total, other adverse events	Teduglutide	10	17
Total, other adverse events	Placebo	12	15
Total, serious adverse events	Teduglutide	0	17
Total, serious adverse events	Placebo	0	15

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL123351	Targeting GI Epithelial Integrity to Improve Arterial Inflammation in HIV	LO, JANET	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2014 to 2018

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Teduglutide vs Placebo: deaths from any cause	Trial comparisons
Teduglutide vs Placebo: serious adverse events	Trial comparisons

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Digit Span Test	Secondary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02431325

GET https://conductscience.org/api/trials/v1/NCT02431325/results?page=2

API reference For AI assistants