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CCR5 Antagonist
Cenicriviroc for HIV-Related Inflammation
Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
Study Summary
This trial will test if a drug can reduce inflammation in the aorta, as seen using imaging techniques.
Who is the study for?
This trial is for people living with HIV who have controlled their virus levels, are on stable antiretroviral therapy, and have a CD4+ count over 200. Participants must be at least 45 years old with cardiovascular risk factors like heart disease or high cholesterol. They can't join if they've had recent serious infections, certain liver issues, drug interactions with CVC, or excessive radiation exposure.Check my eligibility
What is being tested?
The study tests whether cenicriviroc mesylate (CVC), at doses of either 150 mg or 300 mg, can reduce artery inflammation in HIV-positive individuals compared to a placebo. The effect is measured using PET/CT scans of the aorta.See study design
What are the potential side effects?
While specific side effects for CVC aren't listed here, common ones may include gastrointestinal symptoms like nausea or diarrhea, potential liver enzyme changes, fatigue and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in arterial most diseased segment (MDS) 18-FDG-PET target-to-background ratio (TBR) measured in the carotid arteries and aorta
Secondary outcome measures
Change in aortic TBR (and other TBRs)
Change in biomarker of immune activation
Change in biomarker of inflammation
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CVC arm (Arm A)Experimental Treatment2 Interventions
Participants with pre-existing ART regimen of EFV will take CVC 300 mg. Participants with all other pre-existing ARTs will take CVC 150 mg.
Group II: Placebo for CVC arm (Arm B)Placebo Group2 Interventions
Participants with pre-existing ART regimen of EFV will take placebo for CVC 300 mg. Participants with all other pre-existing ARTs will take placebo for CVC 150 mg.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
HIV treatments commonly include antiretroviral drugs that target various stages of the HIV lifecycle. These include reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, and entry inhibitors.
Cenicriviroc Mesylate, a CCR2 and CCR5 antagonist, works by blocking the CCR5 receptor on the surface of T-cells, which HIV uses to enter and infect these cells. This mechanism is crucial for HIV patients as it prevents the virus from entering and replicating within the immune cells, thereby reducing viral load and improving immune function.
By targeting specific receptors like CCR5, these treatments can be more effective in managing HIV and reducing the risk of disease progression.
Effect of female sex work-targeted community-based interventions along the HIV treatment cascade in sub-Saharan Africa: a systematic review protocol.Efficacy of new antiretroviral drugs in treatment-experienced HIV-infected patients: a systematic review and meta-analysis of recent randomized controlled trials.Children with HIV: improved mortality and morbidity with combination antiretroviral therapy.
Effect of female sex work-targeted community-based interventions along the HIV treatment cascade in sub-Saharan Africa: a systematic review protocol.Efficacy of new antiretroviral drugs in treatment-experienced HIV-infected patients: a systematic review and meta-analysis of recent randomized controlled trials.Children with HIV: improved mortality and morbidity with combination antiretroviral therapy.
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,277 Previous Clinical Trials
5,487,360 Total Patients Enrolled
AbbVieIndustry Sponsor
972 Previous Clinical Trials
506,041 Total Patients Enrolled
Janet Lo, MD, MMScStudy ChairMassachusetts General Hospital
2 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone radiation therapy in the past.I have not been vaccinated within the week before my PET/CT scan.I expect to start taking medication to lower my cholesterol during the study.I haven't taken any immune system modifying drugs in the last 30 days.My recent PET/CT scan is clear and approved for study use.I have severe liver problems, including fluid buildup, confusion, or bleeding veins in my stomach.You have a confirmed HIV-1 infection.I haven't taken any medications that could interact with CVC in the last 90 days.My body weight is over 300 pounds or 136 kilograms.I am currently taking high doses of Atorvastatin or Rosuvastatin.I have been diagnosed with a specific infection like TB or toxoplasmosis in the last 3 months.I've been on a stable HIV treatment for over 48 weeks without major interruptions.I have untreated hepatitis B with detectable virus in the last 6 months.Your recent blood and kidney function tests should be within normal range.I have a heart risk like high blood pressure, diabetes, or a family history of heart disease.You have a current hepatitis C virus (HCV) infection.I've had more than two high radiation procedures in the last year.Your HIV levels have been very low for the past 48 weeks before joining the study.I haven't had a serious infection or illness that needed IV antibiotics or hospitalization in the last 3 months.I have or had tuberculosis that was not fully treated.I have not had a heart attack or unstable angina in the last 90 days.I won't get vaccines 7 days before my 24-week study visit.Your HIV test shows very low or undetectable levels of the virus.You have a certain amount of a type of white blood cell called CD4+ cells in your body.I have an active cancer other than squamous cell skin cancer.I am 45 years old or older.Your average blood sugar level (Hemoglobin A1c) is higher than 8% within the last 90 days.I have not started or changed my statin medication in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: CVC arm (Arm A)
- Group 2: Placebo for CVC arm (Arm B)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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