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CompletedNCT05630885Updated Jul 16, 2025Results posted

A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV

A Phase 2 interventional study of CVC 150 mg and CVC 300 mg in HIV-1-infection and Elevated Cardiovascular Risk, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 19 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study summary

The study was conducted to determine if cenicriviroc mesylate (CVC) would decrease vascular inflammation as measured by 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) imaging of the aorta and carotid arteries.

Read the detailed description

This was a double-blind, placebo-controlled phase II clinical trial comparing the intervention of CVC versus placebo for a duration of 24 weeks on arterial inflammation evaluated by FDG-PET/CT imaging.

A total of 110 participants were randomized 2:1 to the CVC arm (Arm A) or placebo for CVC arm (Arm B). Stratification by statin use at randomization ensured even distribution of statin use between the treatment groups.

Analyses were based on the 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.

Analysis of the primary outcome utilized multiple imputation by regression to impute missing data.

02

Conditions studied

  • HIV-1-infection
  • Elevated Cardiovascular Risk

Keywords

  • HIV
  • Vascular Inflammation
03

In context

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 levels.
  4. Current CD4+ cell count >200 cells/mm\^3.

  5. Elevated cardiovascular risk defined as at least one of the following:

    • Clinical atherosclerotic disease (symptomatic atherosclerotic lesions in any vessel)
    • Subclinical atherosclerotic disease (coronary artery calcification [CAC] >10 or presence of non-obstructive plaques)
    • Diabetes mellitus (DM) or prediabetes
    • Obesity
    • Hypertension or blood pressure ≥130/80 mmHg
    • Elevated LDL cholesterol (fasting LDL of >160 mg/dL)
    • Low HDL cholesterol (\<40 mg/dL)
    • Current tobacco smoking
    • Family history of premature coronary artery disease (CAD)
    • hsCRP >2.0 mg/L

Key Exclusion Criteria:

  1. Acute coronary syndrome
  2. A current diagnosis of latent or active tuberculosis (TB) infection
  3. Current diagnosis with other intracellular pathogens (Mycobacterium avium complex, Listeria monocytogenes, Toxoplasma gondii, and Cryptococcus neoformans).
  4. Untreated hepatitis B virus (HBV) infection
  5. Current hepatitis C virus (HCV) infection
  6. Current, acute or clinically significant infection or illness requiring IV antibiotics or hospitalization
  7. History of cirrhosis with severe hepatic impairment and/or hepatic decompensation
  8. Active malignancy, except squamous cell skin cancer.
  9. Hemoglobin A1c >8% within 90 days prior to study entry.
  10. Initiation of statin therapy or change in statin dose within 90 days prior to study entry.

  11. Current use of any of the statins at the doses indicated:

    • Atorvastatin, >40 mg/day dose
    • Rosuvastatin, ≥20 mg/day dose
  12. Concurrent use of drugs with potential drug-drug interactions with CVC within 90 days prior to study entry.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    CVC arm (Arm A)

    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.

    Drug: CVC 150 mg · Drug: CVC 300 mg

  • Placebo comparator
    Placebo for CVC arm (Arm B)

    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.

    Other: Placebo for CVC 150 mg · Other: Placebo for CVC 300 mg

Interventions

  • DrugCVC 150 mg

    Administered as one 150-mg tablet by mouth once a day with food.

  • DrugCVC 300 mg

    Administered as two 150-mg tablets by mouth once a day with food.

  • OtherPlacebo for CVC 150 mg

    Administered as one 150-mg matching placebo tablets by mouth once a day with food.

  • OtherPlacebo for CVC 300 mg

    Administered as two 150-mg matching placebo tablets by mouth once a day with food.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

    Time frame: Measured at baseline and week 24

Secondary outcomes

  1. Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs)

    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.

    Time frame: Measured at baseline and week 24

  2. Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta

    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.

    Time frame: Measured at baseline and week 24

  3. Change in Fasting Glucose

    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.

    Time frame: Measured at baseline and week 24

  4. Change (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)

    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.

    Time frame: Measured at baseline and week 24

  5. Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1)

    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.

    Time frame: Measured at baseline and week 24

  6. Change in Biomarkers of Immune Activation (sCD14 and sCD163)

    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.

    Time frame: Measured at baseline and week 24

  7. Change (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta)

    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.

    Time frame: Measured at baseline and week 24

07

Results

Posted Jul 16, 2025

Participant flow

110 participants were enrolled from 19 US clinical research sites between May 30, 2023 and January 5, 2024.

Study Completion
Participant flow — Study Completion
MilestoneCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
Started7436
Completed7036
Not completed40
Withdrew: Took prohibited medications20
Withdrew: Non-compliance with study drug10
Withdrew: Adverse event10
Efficacy Analysis Population Set
Participant flow — Efficacy Analysis Population Set
MilestoneCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
Started7036
Completed5934
Not completed112
Withdrew: Took prohibited medications31
Withdrew: Prematurely discontinued study treatment before week 2281

Outcome measures

PrimaryChange (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.

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.

Time frame:
Measured at baseline and week 24
Reported as:
Median · 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.
Fold-changeCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
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.0.95 (0.85 to 1.01)0.93 (0.87 to 1.02)
Statistical analysis
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.65 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 0.984 · 95% CI 0.916 to 1.056Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.40 (P-value for modification of the CVC treatment effect by subgroups defined by statin-use is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.)Outcome was log10-transformed. Model adjusted for statin-use and its interaction with treatment. Analysis used multiple imputation for missing data.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.63 (P-value for modification of the CVC treatment effect by subgroups defined by sex is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.)Outcome was log10-transformed. Model adjusted for sex (F vs M) and its interaction with treatment. Analysis used multiple imputation for missing data.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.71 (P-value for modification of the CVC treatment effect by subgroups defined by race is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.)Outcome was log10-transformed. Model adjusted for race and its interaction with treatment. Analysis used multiple imputation for missing data.
SecondaryChange (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs)

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.

Time frame:
Measured at baseline and week 24
Reported as:
Median · Fold-change
Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs)
Fold-changeCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
Aorta TBR1.00 (0.93 to 1.09)0.99 (0.91 to 1.11)
Bilateral Carotid TBR0.99 (0.89 to 1.09)1.02 (0.89 to 1.11)
Statistical analysis
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.91 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 0.996 · 95% CI 0.930 to 1.067Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.64 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 0.980 · 95% CI 0.901 to 1.066Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.
SecondaryChange (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta

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.

Time frame:
Measured at baseline and week 24
Reported as:
Median · Fold-change
Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta
Fold-changeCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
Aorta SUV1.00 (0.93 to 1.11)1.00 (0.88 to 1.10)
Bilateral Carotid SUV1.02 (0.94 to 1.11)1.00 (0.89 to 1.06)
Statistical analysis
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.79 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 1.010 · 95% CI 0.939 to 1.087Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.69 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 1.017 · 95% CI 0.935 to 1.106Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.
SecondaryChange in Fasting Glucose

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.

Time frame:
Measured at baseline and week 24
Reported as:
Median · mg/dL
Change in Fasting Glucose
mg/dLCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
Change in Fasting Glucose1.00 (-9.00 to 8.00)-0.50 (-13.00 to 8.00)
Statistical analysis
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.49 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 2.5 · 95% CI -4.6 to 9.6Estimate reflects the relative mean change in fasting glucose from baseline for CVC compared to placebo.
SecondaryChange (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)

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.

Time frame:
Measured at baseline and week 24
Reported as:
Median · Fold-change
Change (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
Fold-changeCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
Fasting insulin0.91 (0.67 to 1.28)0.89 (0.57 to 1.31)
HOMA-IR0.85 (0.63 to 1.37)0.90 (0.46 to 1.48)
Statistical analysis
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.62 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 1.07 · 95% CI 0.81 to 1.43Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in fasting insulin from baseline for CVC compared to placebo.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.61 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 1.09 · 95% CI 0.78 to 1.54Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in HOMA-IR from baseline for CVC compared to placebo.
SecondaryChange (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1)

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.

Time frame:
Measured at baseline and week 24
Reported as:
Median · Fold-change
Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1)
Fold-changeCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
hsCRP0.85 (0.51 to 1.30)0.84 (0.61 to 1.48)
Interleukin-60.99 (0.78 to 1.64)1.10 (0.71 to 1.56)
MCP-15.00 (3.96 to 6.04)0.99 (0.86 to 1.36)
Statistical analysis
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.91 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 0.97 · 95% CI 0.62 to 1.52Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in hsCRP from baseline for CVC compared to placebo.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.94 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 1.01 · 95% CI 0.77 to 1.33Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in IL-6 from baseline for CVC compared to placebo.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = <0.001 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 4.74 · 95% CI 3.89 to 5.77Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MCP-1 from baseline for CVC compared to placebo.
SecondaryChange in Biomarkers of Immune Activation (sCD14 and sCD163)

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.

Time frame:
Measured at baseline and week 24
Reported as:
Median · ng/mL
Change in Biomarkers of Immune Activation (sCD14 and sCD163)
ng/mLCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
Soluble CD14-16.2 (-147 to 112)6.66 (-115 to 155)
Soluble CD163-21.8 (-93.9 to 50.5)17.4 (-67.3 to 68.8)
Statistical analysis
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.38 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: -49 · 95% CI -158 to 60Estimate reflects the relative mean change in sCD14 from baseline for CVC compared to placebo.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.88 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: -6.3 · 95% CI -87 to 75Estimate reflects the relative mean change in sCD163 from baseline for CVC compared to placebo.
SecondaryChange (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta)

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.

Time frame:
Measured at baseline and week 24
Reported as:
Median · Fold-change
Change (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta)
Fold-changeCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
MIP-1 beta2.44 (1.82 to 3.54)1.07 (0.92 to 2.07)
RANTES0.98 (0.80 to 1.22)1.06 (0.92 to 1.29)
Statistical analysis
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = <0.001 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 1.65 · 95% CI 1.28 to 2.12Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MIP-1 beta from baseline for CVC compared to placebo.
  • CVC Arm (Arm A) vs Placebo for CVC Arm (Arm B) · Regression, Linear · p = 0.85 (A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.) · Slope: 1.02 · 95% CI 0.82 to 1.28Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in RANTES from baseline for CVC compared to placebo.

Adverse events

Collected over From study entry to completion at Week 24 or premature study discontinuation.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CVC Arm (Arm A)0/74 (0%)4/74 (5.4%)44/74 (59.5%)
Placebo for CVC Arm (Arm B)0/36 (0%)2/36 (5.6%)20/36 (55.6%)
Most frequent serious events
Most frequent serious events
EventCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
Cerebrovascular accidentNervous system disorders0/741/36
Urinary retentionRenal and urinary disorders0/741/36
Respiratory tract infection viralInfections and infestations1/740/36
Blood triglycerides increasedInvestigations1/740/36
MyelopathyNervous system disorders1/740/36
Intentional self-injuryPsychiatric disorders1/740/36
PriapismReproductive system and breast disorders1/740/36
Most frequent other events
Showing 10 of 45
Most frequent other events
EventCVC Arm (Arm A)Placebo for CVC Arm (Arm B)
Glomerular filtration rate decreasedInvestigations21/745/36
Creatinine renal clearance decreasedInvestigations5/744/36
Blood glucose increasedInvestigations4/743/36
COVID-19Infections and infestations6/742/36
Blood triglycerides increasedInvestigations1/742/36
Amylase increasedInvestigations4/741/36
ColitisGastrointestinal disorders0/741/36
Gastrooesophageal reflux diseaseGastrointestinal disorders0/741/36
ParonychiaInfections and infestations0/741/36
SinusitisInfections and infestations2/741/36

Baseline characteristics

Population is based on enrolled participants who initiated study treatment.

Age, Continuous
Age, Continuous(years)CVC Arm (Arm A)Placebo for CVC Arm (Arm B)Total
Median58 (51 to 62)58 (54 to 65)58 (53 to 63)
Age, Customized
Age, Customized(Participants)CVC Arm (Arm A)Placebo for CVC Arm (Arm B)Total
Age Groups — 45-54251136
Age Groups — 55-64371653
Age Groups — 65-7412820
Age Groups — 75+011
Sex: Female, Male
Sex: Female, Male(Participants)CVC Arm (Arm A)Placebo for CVC Arm (Arm B)Total
Female23730
Male512980
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CVC Arm (Arm A)Placebo for CVC Arm (Arm B)Total
Hispanic or Latino13821
Not Hispanic or Latino612889
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CVC Arm (Arm A)Placebo for CVC Arm (Arm B)Total
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American261238
White462470
More than one race000
Unknown or Not Reported202
Gender Identity
Gender Identity(Participants)CVC Arm (Arm A)Placebo for CVC Arm (Arm B)Total
Cisgender7236108
Transgender Spectrum202
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)CVC Arm (Arm A)Placebo for CVC Arm (Arm B)Total
Median28.5 (25.5 to 32.2)28.7 (24.6 to 33.2)28.5 (25.1 to 32.8)
BMI Groups
BMI Groups(Participants)CVC Arm (Arm A)Placebo for CVC Arm (Arm B)Total
Underweight (< 18.5)000
Normal (18.5 - 24.9)161127
Overweight (25 - 29.9)31839
Obese (30+)271744

28 further baseline measures are reported on the registry.

08

Study locations

19 sites
  • University of California, Los Angeles CARE Center CRS (Site # 601)
    Los Angeles, California 90035, United States
  • UCSD Antiviral Research Center CRS (Site # 701)
    San Diego, California 92103, United States
  • UCSF HIV/AIDS CRS (Site # 801)
    San Francisco, California 94110, United States
  • Harbor University of California Los Angeles Center CRS (Site # 603)
    Torrance, California 90502, United States
  • Northwestern University CRS (Site # 2701)
    Chicago, Illinois 60611, United States
  • Massachusetts General Hospital CRS (MGH CRS) (Site # 101)
    Boston, Massachusetts 02114, United States
  • Brigham and Women's Hospital Therapeutics (BWH TCRS) CRS (Site # 107)
    Boston, Massachusetts 02115, United States
  • Washington University Therapeutics (WT) CRS (Site # 2101)
    St Louis, Missouri 63110-1010, United States
  • Weill Cornell Chelsea CRS (Site # 7804)
    New York, New York 10010, United States
  • Weill Cornell Uptown CRS (Site # 7803)
    New York, New York 10065, United States
  • University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site # 31787)
    Rochester, New York 14642, United States
  • Chapel Hill CRS (Site # 3201)
    Chapel Hill, North Carolina 27599-7215, United States
  • Cincinnati CRS (Site # 2401)
    Cincinnati, Ohio 45267-0405, United States
  • Case CRS (Site # 2501)
    Cleveland, Ohio 44106, United States
  • Ohio State University CRS (Site # 2301)
    Columbus, Ohio 43210-1282, United States
  • University of Pittsburgh CRS (Site # 1001)
    Pittsburgh, Pennsylvania 15213, United States
  • Vanderbilt Therapeutics (VT) CRS (Site # 3652)
    Nashville, Tennessee 37204, United States
  • Houston AIDS Research Team CRS (Site # 31473)
    Houston, Texas 77030, United States
  • University of Washington Positive Research CRS (Site # 1401)
    Seattle, Washington 98104, United States
09

References and documents

Study documents

  • Protocol and informed consent form · Mar 22, 2024
  • Statistical analysis plan · Jul 18, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Results will be published in a manuscript and supporting information submitted to NHLBI BioData Catalyst® (BDC) (including data dictionaries and case report forms).

Supporting information: Study protocol, Sap

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05630885
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
AbbVie
Responsible party
Sponsor
First posted
Nov 30, 2022
Start date
May 30, 2023
Primary completion
Jun 19, 2024
Completion
Jun 19, 2024
Results posted
Jul 16, 2025
Last update
Jul 16, 2025

Study contacts

Janet Lo, MD, MMSc
study chair · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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