Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02431325 | A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV | PHASE2 | COMPLETED | 32 | — | — | Dec 1, 2015 | Jan 21, 2021 | Jun 12, 2023 | 1 | United States |
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 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.
Soluble CD14 is a marker of monocyte activation. An increase in soluble CD14 concentration indicates an increase in inflammation.
| Arm | Type | Description |
|---|---|---|
| Teduglutide | EXPERIMENTAL | Teduglutide, subcutaneous injection, 0.05 mg/kg/day, 6 months duration |
| Placebo | PLACEBO_COMPARATOR | Placebo, subcutaneous injection, 6 months duration |
| Name | Type | Description |
|---|---|---|
| Teduglutide | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Men and women age 21-65 with previously diagnosed HIV disease 2. Stable anti-retroviral therapy (ART) as defined by no changes in ART regimen for \>6 months 3. HIV viral load \< 200 copies/mL 4. To be eligible for colonoscopy procedure, laboratory values that meet the followi...