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

Prior treatment

• Initiation of statin therapy or change in statin dose within 90 days prior to study entry.
• Concurrent use of drugs with potential drug-drug interactions with CVC within 90 days prior to study entry.

Other illness

• Acute coronary syndrome
• A current diagnosis of latent or active tuberculosis (TB) infection
• 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.

Lab values

• Hemoglobin A1c \>8% within 90 days prior to study entry.

Other

• Current diagnosis with other intracellular pathogens (Mycobacterium avium complex, Listeria monocytogenes, Toxoplasma gondii, and Cryptococcus neoformans).
• Current use of any of the statins at the doses indicated:
  • Atorvastatin, \>40 mg/day dose
  • Rosuvastatin, ≥20 mg/day dose

• 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 (\<40 mg/dL)
  • Current tobacco smoking
  • Family history of premature coronary artery disease (CAD)
  • hsCRP \>2.0 mg/L