What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapy (ART), can have a range of side effects. For CCR2 and CCR5 antagonists like Cenicriviroc Mesylate, potential side effects may include gastrointestinal issues (nausea, diarrhea), fatigue, and headaches. Broader ART regimens can also cause side effects such as liver toxicity, cardiovascular issues, and metabolic changes like lipid abnormalities. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several antiretroviral drugs for the treatment of HIV, including those targeting CCR5 receptors, similar to Cenicriviroc Mesylate. One notable example is Maraviroc, a CCR5 antagonist that prevents HIV from entering and infecting immune cells. Additionally, other classes of antiretroviral drugs have been approved, such as reverse transcriptase inhibitors (e.g., Zidovudine), protease inhibitors, and integrase inhibitors, which collectively form the backbone of combination antiretroviral therapy (ART) used to manage HIV infection.

What other types of research exist?

Promising novel alternatives to Cenicriviroc Mesylate for HIV patients include: 1) Lenacapavir, a long-acting capsid inhibitor, which has shown efficacy in heavily treatment-experienced patients. 2) Islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), which is being developed for both treatment and prevention of HIV. 3) Cabotegravir, a long-acting integrase strand transfer inhibitor (INSTI), used in combination with Rilpivirine for a once-monthly injectable regimen. These alternatives offer different mechanisms of action and dosing regimens, potentially improving adherence and outcomes for HIV patients.

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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

Must not have

History of radiation therapy

Treatment within 30 days prior to study entry or anticipated treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons, cyclosporine, and tacrolimus)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24

Summary

This trial is testing a drug called CVC to see if it can reduce inflammation in the blood vessels of people with vascular inflammation. The drug aims to calm down artery inflammation, and this effect is checked using special 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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have undergone radiation therapy in the past.

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I haven't taken any immune system modifying drugs in the last 30 days.

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I am currently taking high doses of Atorvastatin or Rosuvastatin.

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I have severe liver problems, including fluid buildup, confusion, or bleeding veins in my stomach.

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My body weight is over 300 pounds or 136 kilograms.

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I haven't had a serious infection or illness that needed IV antibiotics or hospitalization in the last 3 months.

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I have or had tuberculosis that was not fully treated.

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I have an active cancer other than squamous cell skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in arterial most diseased segment (MDS) 18-FDG-PET target-to-background ratio (TBR) measured in the carotid arteries and aorta

Secondary study objectives

Change in biomarker of immune activation

Change in biomarker of inflammation

Trial 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CVC 300 mg

2023

Completed Phase 2

~110

CVC 150 mg

2023

Completed Phase 2

~110

0 / 8Eligibility criteria met

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.