Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02431325 · ClinicalTrials.gov registry record · Phase 2
A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT02431325: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT02431325 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02431325, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Teduglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-12 |
| Est. Completion | 2021-01-21 |
| Phase | Phase 2 |
What the finished NCT02431325 record still lists
NCT02431325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02431325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02431325 about?
NCT02431325 is a clinical study titled "A Study of the Gut Barrier and Blood Vessel 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 leakines...
What is the current status of trial NCT02431325?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2015-12. Estimated completion is 2021-01-21.
What interventions are being tested in trial NCT02431325?
The interventions under investigation include: Placebo (DRUG), Teduglutide (DRUG).
Who is sponsoring clinical trial NCT02431325?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02431325's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02445781 · 32 participants · Early Phase 1
Differing Levels of Hypoglycemia
- NCT02792270 · 32 participants · NA
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
- NCT03068910 · 32 participants · Early Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
- NCT03208868 · 32 participants · NA
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia