Trial · NCT05630885
A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV
NCT05630885, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2025-07-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV. Trials, record NCT05630885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05630885
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV
- NCT number
- NCT05630885
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- HIV-1-infection, Elevated Cardiovascular Risk
- Interventions
- CVC 150 mg, CVC 300 mg, Placebo for CVC 150 mg, Placebo for CVC 300 mg
- First posted
- 2022-11-30
- Last updated
- 2025-07-16
- Results first posted
- 2025-07-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change (Expressed as Ratio to Baseline) in 18-FDG-PET Target-to-background Ratio (TBR) of the Most Diseased Segment (MDS) of the Index (Most-inflamed) Vessel. | Measured at baseline and week 24 | 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. |
| Secondary | Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs) | Measured at baseline and week 24 | 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 Standard 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 implies a reduction in the target arterial wall inflammation over time. The results are expressed as the ratio of TBR at week 24 to baseline. |
| Secondary | Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta | Measured at baseline and week 24 | Standard Uptake Value (SUV) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid). Specifically, it is the average of all evaluable SUV for a given arterial vessel. A negative number for the change in SUV implies a reduction in the target arterial wall inflammation over time. The results are expressed as the ratio of SUV at week 24 to baseline. |
| Secondary | Change in Fasting Glucose | Measured at baseline and week 24 | Fasting glucose (mg/dL) measures the level of sugar (glucose) in the blood after fasting (no eating or drinking except water) for at least 8 hours. Higher value of change means an increase in glucose levels over time. The results are expressed as the change in fasting glucose from baseline to week 24. |
| Secondary | Change (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR) | Measured at baseline and week 24 | Insulin is a hormone crucial in regulating blood sugar levels. HOMA-IR is a calculation used to assess insulin resistance and is calculated with the formula: insulin (uIU/mL) \* glucose (mg/dL) / 405. Higher value of change in insulin and HOMA-IR means an increase in insulin resistance over time. The results are expressed as the ratio of fasting insulin or HOMA-IR at week 24 to baseline. |
| Secondary | Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1) | Measured at baseline and week 24 | The cytokine, Interleukin-6 (IL-6, pg/mL); protein, high-sensitivity C Reactive Protein (hsCRP, mg/L); and chemokine, monocyte chemoattractant protein-1 (MCP-1, pg/mL) are all markers of inflammation. Higher value of change means an increase in the biomarker levels over time. Higher levels of these biomarkers indicates inflammation. MCP-1 is a ligand of CCR2 that was expected to increase with CVC. The results are expressed as the ratio of hsCRP, IL-6, or MCP-1 at week 24 to baseline. |
| Secondary | Change in Biomarkers of Immune Activation (sCD14 and sCD163) | Measured at baseline and week 24 | The soluble proteins soluble-CD14 (sCD14, ng/mL) and soluble-CD163 (sCD163, ng/mL) are all markers of monocyte/macrophage activation. Higher value of change means an increase in the biomarker levels over time. Higher levels of sCD14 and sCD163 occur in response to inflammation and infection. The results are expressed as the difference between sCD14 or sCD163 from baseline to week 24. |
| Secondary | Change (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta) | Measured at baseline and week 24 | The chemokines macrophage inflammatory protein-1 alpha and beta (MIP-1 alpha and beta, pg/mL) as well as the chemokine, RANTES (ng/mL), are markers of inflammation. Higher value of change means an increase in the biomarker levels over time. Higher levels of these biomarkers indicates inflammation. RANTES and MIP-1 beta are ligands of CCR5 that were expected to increase with CVC. The results are expressed as the ratio of RANTES or MIP-1 beta at week 24 to baseline. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change (Expressed as Ratio to Baseline) in 18-FDG-PET Target-to-background Ratio (TBR) of the Most Diseased Segment (MDS) of the Index (Most-inflamed) Vessel. | Measured at baseline and week 24 | Efficacy population: all enrolled participants who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications. | Fold-change | MEDIAN |
| SECONDARY | Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs) | Measured at baseline and week 24 | Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications. | Fold-change | MEDIAN |
| SECONDARY | Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta | Measured at baseline and week 24 | Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications. | Fold-change | MEDIAN |
| SECONDARY | Change in Fasting Glucose | Measured at baseline and week 24 | Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications. | mg/dL | MEDIAN |
| SECONDARY | Change (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR) | Measured at baseline and week 24 | Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications. | Fold-change | MEDIAN |
| SECONDARY | Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1) | Measured at baseline and week 24 | Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications. | Fold-change | MEDIAN |
| SECONDARY | Change in Biomarkers of Immune Activation (sCD14 and sCD163) | Measured at baseline and week 24 | Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications. | ng/mL | MEDIAN |
| SECONDARY | Change (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta) | Measured at baseline and week 24 | Efficacy population with evaluable records: all enrolled participants with evaluable records who completed at least 22 weeks of study treatment and remained on the same ART drug class throughout the study without use of prohibited medications. | Fold-change | MEDIAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change (Expressed as Ratio to Baseline) in 18-FDG-PET Target-to-background Ratio (TBR) of the Most Diseased Segment (MDS) of the Index (Most-inflamed) Vessel. | CVC Arm (Arm A) | 0.95 | Inter-Quartile Range 0.85 to 1.01 | Fold-change | |
| Change (Expressed as Ratio to Baseline) in 18-FDG-PET Target-to-background Ratio (TBR) of the Most Diseased Segment (MDS) of the Index (Most-inflamed) Vessel. | Placebo for CVC Arm (Arm B) | 0.93 | Inter-Quartile Range 0.87 to 1.02 | Fold-change | |
| Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs) | CVC Arm (Arm A) | Aorta TBR | 1.00 | Inter-Quartile Range 0.93 to 1.09 | Fold-change |
| Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs) | Placebo for CVC Arm (Arm B) | Aorta TBR | 0.99 | Inter-Quartile Range 0.91 to 1.11 | Fold-change |
| Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs) | CVC Arm (Arm A) | Bilateral Carotid TBR | 0.99 | Inter-Quartile Range 0.89 to 1.09 | Fold-change |
| Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs) | Placebo for CVC Arm (Arm B) | Bilateral Carotid TBR | 1.02 | Inter-Quartile Range 0.89 to 1.11 | Fold-change |
| Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta | CVC Arm (Arm A) | Aorta SUV | 1.00 | Inter-Quartile Range 0.93 to 1.11 | Fold-change |
| Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta | Placebo for CVC Arm (Arm B) | Aorta SUV | 1.00 | Inter-Quartile Range 0.88 to 1.10 | Fold-change |
| Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta | CVC Arm (Arm A) | Bilateral Carotid SUV | 1.02 | Inter-Quartile Range 0.94 to 1.11 | Fold-change |
| Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta | Placebo for CVC Arm (Arm B) | Bilateral Carotid SUV | 1.00 | Inter-Quartile Range 0.89 to 1.06 | Fold-change |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Completion | STARTED | CVC Arm (Arm A) | 74 | |
| Study Completion | STARTED | Placebo for CVC Arm (Arm B) | 36 | |
| Study Completion | COMPLETED | CVC Arm (Arm A) | 70 | |
| Study Completion | COMPLETED | Placebo for CVC Arm (Arm B) | 36 | |
| Study Completion | NOT COMPLETED | CVC Arm (Arm A) | 4 | |
| Study Completion | NOT COMPLETED | Placebo for CVC Arm (Arm B) | 0 | |
| Efficacy Analysis Population Set | STARTED | CVC Arm (Arm A) | 70 | |
| Efficacy Analysis Population Set | STARTED | Placebo for CVC Arm (Arm B) | 36 | |
| Efficacy Analysis Population Set | COMPLETED | CVC Arm (Arm A) | 59 | |
| Efficacy Analysis Population Set | COMPLETED | Placebo for CVC Arm (Arm B) | 34 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
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 | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | CVC Arm (Arm A) | 1 | 74 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo for CVC Arm (Arm B) | 0 | 36 | |
| other | Anal fissure | Gastrointestinal disorders | CVC Arm (Arm A) | 1 | 74 | |
| other | Anal fissure | Gastrointestinal disorders | Placebo for CVC Arm (Arm B) | 0 | 36 | |
| other | Colitis | Gastrointestinal disorders | CVC Arm (Arm A) | 0 | 74 | |
| other | Colitis | Gastrointestinal disorders | Placebo for CVC Arm (Arm B) | 1 | 36 | |
| other | Diarrhoea | Gastrointestinal disorders | CVC Arm (Arm A) | 1 | 74 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo for CVC Arm (Arm B) | 0 | 36 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | CVC Arm (Arm A) | 0 | 74 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo for CVC Arm (Arm B) | 1 | 36 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CVC Arm (Arm A) | 0 | 74 |
| Total, all-cause mortality | Placebo for CVC Arm (Arm B) | 0 | 36 |
| Total, other adverse events | CVC Arm (Arm A) | 44 | 74 |
| Total, other adverse events | Placebo for CVC Arm (Arm B) | 20 | 36 |
| Total, serious adverse events | CVC Arm (Arm A) | 4 | 74 |
| Total, serious adverse events | Placebo for CVC Arm (Arm B) | 2 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B): deaths from any cause | Trial comparisons |
| CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT05630885
GET https://conductscience.org/api/trials/v1/NCT05630885/results?page=2