NCT04334915

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of cenicriviroc mesylate (CVC) on arterial inflammation in people living with HIV.

Detailed description

This study will evaluate the effects of cenicriviroc mesylate (CVC) on arterial inflammation in people living with HIV. Participants will be randomized to either the CVC arm (Arm A) or placebo for CVC arm (Arm B). CVC 150 mg or placebo for CVC will be added to the participants' pre-existing antiretroviral (ARV) regimens once a day for at least 24 weeks. For participants who are on an efavirenz (EFV)-based regimen, dosing will be 300 mg once a day. Study participants will remain on study treatment for approximately 24 weeks. Study visits may include blood collection, physical examinations, and FDG-PET/CT imaging.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Cenicriviroc Mesylate (CVC)	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2022-11-22
• Primary completion: 2024-08-15
• Completion: 2024-08-15
• First posted: 2020-04-06
• Last updated: 2022-12-21

Regulatory

• FDA-regulated drug study