NCT05630885

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

A Limited-Center, Prospective, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HIV-1-infection
• Elevated Cardiovascular Risk

Interventions

Type	Name	Description
DRUG	CVC 150 mg	Administered as one 150-mg tablet by mouth once a day with food.
DRUG	CVC 300 mg	Administered as two 150-mg tablets by mouth once a day with food.
OTHER	Placebo for CVC 150 mg	Administered as one 150-mg matching placebo tablets by mouth once a day with food.
OTHER	Placebo for CVC 300 mg	Administered as two 150-mg matching placebo tablets by mouth once a day with food.

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-06-19
• Completion: 2024-06-19
• First posted: 2022-11-30
• Last updated: 2025-07-16
• Results posted: 2025-07-16

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study