Phase 2
N=110
A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV
HIV-1-infection · Elevated Cardiovascular Risk
Bottom Line
View on ClinicalTrials.gov: NCT05630885 ↗Enrolled (actual)
110
Serious AEs
5.5%
Results posted
Jul 2025
Primary outcome: 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. — 0.95; 0.93 Fold-change — p=0.65
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CVC 150 mg (Drug); CVC 300 mg (Drug); Placebo for CVC 150 mg (Other); Placebo for CVC 300 mg (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
0.95; 0.93 | 0.65 |
| SECONDARY Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs) |
1.00; 0.99; 0.99; 1.02 | 0.91 |
| SECONDARY Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta |
1.00; 1.00; 1.02; 1.00 | 0.79 |
| SECONDARY Change in Fasting Glucose |
1.00; -0.50 | 0.49 |
| SECONDARY Change (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR) |
0.91; 0.89; 0.85; 0.90 | 0.62 |
| SECONDARY Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1) |
0.85; 0.84; 0.99; 1.10; 5.00; 0.99 | 0.91 |
| SECONDARY Change in Biomarkers of Immune Activation (sCD14 and sCD163) |
-16.2; 6.66; -21.8; 17.4 | 0.38 |
| SECONDARY Change (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta) |
2.44; 1.07; 0.98; 1.06 | <0.001 sig |
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.
Eligibility Criteria
Key Inclusion Criteria
- Documented to be living with HIV-1 infection.
- 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.
- At least a year of controlled HIV-1 RNA levels.
- Current CD4+ cell count >200 cells/mm^3.
- 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 ( 2.0 mg/L
Key Exclusion Criteria
- Acute coronary syndrome
- A current diagnosis of latent or active tuberculosis (TB) infection
- Current diagnosis with other intracellular pathogens (Mycobacterium avium complex, Listeria monocytogenes, Toxoplasma gondii, and Cryptococcus neoformans).
- Untreated hepatitis B virus (HBV) infection
- Current hepatitis C virus (HCV) infection
- Current, acute or clinically significant infection or illness requiring IV antibiotics or hospitalization
- History of cirrhosis with severe hepatic impairment and/or hepatic decompensation
- Active malignancy, except squamous cell skin cancer.
- Hemoglobin A1c >8% within 90 days prior to study entry.
- Initiation of statin therapy or change in statin dose within 90 days prior to study entry.
- Current use of any of the statins at the doses indicated:
- Atorvastatin, >40 mg/day dose
- Rosuvastatin, ≥20 mg/day dose
- Concurrent use of drugs with potential drug-drug interactions with CVC within 90 days prior to study entry.
Data sourced from ClinicalTrials.gov (NCT05630885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.