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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05630885 | A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV | PHASE2 | COMPLETED | 110 | — | — | May 30, 2023 | Jun 19, 2024 | Jul 16, 2025 | 19 | United States |
Target-to-Background Ratio (TBR) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid), relative to its respective blood background. Specifically, it is the ratio of the Standardized Uptake Value (SUV) of 18-FDG-PET in the target vessel to SUV in the blood background. A negative number for the change in TBR means a reduction in the target arterial wall inflammation over time. Index vessel is the vessel with the highest vessel TBR at baseline. 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 ratio of TBR at week 24 to baseline. For the statistical analyses, results for the 6 and 9 missing values in Arm A and Arm B, respectively, were imputed using multiple imputation by regression.
| Arm | Type | Description |
|---|---|---|
| CVC arm (Arm A) | EXPERIMENTAL | Participants with pre-existing ART regimen of efavirenz (EFV) took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg. |
| Placebo for CVC arm (Arm B) | PLACEBO_COMPARATOR | Participants with pre-existing ART regimen of efavirenz (EFV) took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg. |
| Name | Type | Description |
|---|---|---|
| CVC 150 mg | DRUG | Administered as one 150-mg tablet by mouth once a day with food. |
| CVC 300 mg | DRUG | Administered as two 150-mg tablets by mouth once a day with food. |
| Placebo for CVC 150 mg | OTHER | Administered as one 150-mg matching placebo tablets by mouth once a day with food. |
| Placebo for CVC 300 mg | OTHER | Administered as two 150-mg matching placebo tablets by mouth once a day with food. |
Key Inclusion Criteria: 1. Documented to be living with HIV-1 infection. 2. Currently on a stable, continuous NNRTI-based or unboosted INSTI-based ART regimen for ≥48 weeks prior to study entry with no plans to change ART during the course of the study. 3. At least a year of controlled HIV-1 RNA le...