HIV-1-infectionPhase 2NCT05630885
A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV
A Phase 2 study testing CVC 150 mg and CVC 300 mg in people with HIV-1-infection and Elevated Cardiovascular Risk, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- HIV-1-infection, Elevated Cardiovascular Risk
- What is being tested?
- CVC 150 mg and CVC 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 19 sitesUnited States
- Study dates
- 30 May 2023to 19 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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
Who cannot join
- Acute coronary syndrome
- A current diagnosis of latent or active tuberculosis (TB) infection
- Current diagnosis with other intracellular pathogens (Mycobacterium avium complex, Listeria monocytogenes, Toxoplasma gondii, and Cryptococcus neoformans).
- 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
Show all 14Show fewer
- History of cirrhosis with severe hepatic impairment and/or hepatic decompensation
- Active malignancy, except squamous cell skin cancer.
- Hemoglobin A1c >8% within 90 days prior to study entry.
- Initiation of statin therapy or change in statin dose within 90 days prior to study entry.
- Current use of any of the statins at the doses indicated:
- Atorvastatin, >40 mg/day dose
- Rosuvastatin, ≥20 mg/day dose
- Concurrent use of drugs with potential drug-drug interactions with CVC within 90 days prior to study entry.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Massachusetts General Hospital CRS (MGH CRS) (Site # 101)
Boston, Massachusetts, 02114
Brigham and Women's Hospital Therapeutics (BWH TCRS) CRS (Site # 107)
Boston, Massachusetts, 02115
Chapel Hill CRS (Site # 3201)
Chapel Hill, North Carolina, 27599-7215
Northwestern University CRS (Site # 2701)
Chicago, Illinois, 60611
Cincinnati CRS (Site # 2401)
Cincinnati, Ohio, 45267-0405
Case CRS (Site # 2501)
Cleveland, Ohio, 44106
Ohio State University CRS (Site # 2301)
Columbus, Ohio, 43210-1282
Houston AIDS Research Team CRS (Site # 31473)
Houston, Texas, 77030
University of California, Los Angeles CARE Center CRS (Site # 601)
Los Angeles, California, 90035
Vanderbilt Therapeutics (VT) CRS (Site # 3652)
Nashville, Tennessee, 37204
Weill Cornell Chelsea CRS (Site # 7804)
New York, New York, 10010
Weill Cornell Uptown CRS (Site # 7803)
New York, New York, 10065
University of Pittsburgh CRS (Site # 1001)
Pittsburgh, Pennsylvania, 15213
University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site # 31787)
Rochester, New York, 14642
UCSD Antiviral Research Center CRS (Site # 701)
San Diego, California, 92103
UCSF HIV/AIDS CRS (Site # 801)
San Francisco, California, 94110
University of Washington Positive Research CRS (Site # 1401)
Seattle, Washington, 98104
Washington University Therapeutics (WT) CRS (Site # 2101)
St Louis, Missouri, 63110-1010
Harbor University of California Los Angeles Center CRS (Site # 603)
Torrance, California, 90502
About this study
Official title: A Limited-Center, Prospective, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV
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.
Read the 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
- Being tested
- CVC 150 mg, CVC 300 mg, Placebo for CVC 150 mg, Placebo for CVC 300 mg
- Keywords
- HIV, Vascular Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVC 150 mgDrug
Administered as one 150-mg tablet by mouth once a day with food.
CVC 300 mgDrug
Administered as two 150-mg tablets by mouth once a day with food.
Placebo for CVC 150 mgOther
Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Placebo for CVC 300 mgOther
Administered as two 150-mg matching placebo tablets by mouth once a day with food.
| Study group | Role | What they receive |
|---|---|---|
| CVC arm (Arm A) | Experimental | Participants with pre-existing ART regimen of efavirenz (EFV) took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg. Receives: Drug: CVC 150 mg; Drug: CVC 300 mg |
| Placebo for CVC arm (Arm B) | Placebo comparator | Participants with pre-existing ART regimen of efavirenz (EFV) took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg. Receives: Other: Placebo for CVC 150 mg; Other: Placebo for CVC 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (Expressed as Ratio to Baseline) in 18-FDG-PET Target-to-background Ratio (TBR) of the Most Diseased Segment (MDS) of the Index (Most-inflamed) Vessel.
Target-to-Background Ratio (TBR) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid), relative to its respective blood background. Specifically, it is the ratio of the Standardized Uptake Value (SUV) of 18-FDG-PET in the target vessel to SUV in the blood background. A negative number for the change in TBR means a reduction in the target arterial wall inflammation over time.
Index vessel is the vessel with the highest vessel TBR at baseline.
The most diseased segment is the approximately 1-cm section of the vessel with the highest activity at baseline.
The results are expressed as the ratio of TBR at week 24 to baseline.
For the statistical analyses, results for the 6 and 9 missing values in Arm A and Arm B, respectively, were imputed using multiple imputation by regression.
Measured: Measured at baseline and week 24
Secondary outcomes (7)
Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs)
Target-to-Background Ratio (TBR) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid), relative to its respective blood background. Specifically, it is the ratio of the Standard Uptake Value (SUV) of 18-FDG-PET in the target vessel to SUV in the blood background. A negative number for the change in TBR implies a reduction in the target arterial wall inflammation over time.
The results are expressed as the ratio of TBR at week 24 to baseline.
Measured: Measured at baseline and week 24
Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta
Standard Uptake Value (SUV) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid). Specifically, it is the average of all evaluable SUV for a given arterial vessel. A negative number for the change in SUV implies a reduction in the target arterial wall inflammation over time.
The results are expressed as the ratio of SUV at week 24 to baseline.
Measured: Measured at baseline and week 24
Change in Fasting Glucose
Fasting glucose (mg/dL) measures the level of sugar (glucose) in the blood after fasting (no eating or drinking except water) for at least 8 hours. Higher value of change means an increase in glucose levels over time.
The results are expressed as the change in fasting glucose from baseline to week 24.
Measured: Measured at baseline and week 24
Change (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
Insulin is a hormone crucial in regulating blood sugar levels. HOMA-IR is a calculation used to assess insulin resistance and is calculated with the formula: insulin (uIU/mL) * glucose (mg/dL) / 405. Higher value of change in insulin and HOMA-IR means an increase in insulin resistance over time.
The results are expressed as the ratio of fasting insulin or HOMA-IR at week 24 to baseline.
Measured: Measured at baseline and week 24
Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1)
The cytokine, Interleukin-6 (IL-6, pg/mL); protein, high-sensitivity C Reactive Protein (hsCRP, mg/L); and chemokine, monocyte chemoattractant protein-1 (MCP-1, pg/mL) are all markers of inflammation. Higher value of change means an increase in the biomarker levels over time. Higher levels of these biomarkers indicates inflammation.
MCP-1 is a ligand of CCR2 that was expected to increase with CVC.
The results are expressed as the ratio of hsCRP, IL-6, or MCP-1 at week 24 to baseline.
Measured: Measured at baseline and week 24
Change in Biomarkers of Immune Activation (sCD14 and sCD163)
The soluble proteins soluble-CD14 (sCD14, ng/mL) and soluble-CD163 (sCD163, ng/mL) are all markers of monocyte/macrophage activation. Higher value of change means an increase in the biomarker levels over time. Higher levels of sCD14 and sCD163 occur in response to inflammation and infection.
The results are expressed as the difference between sCD14 or sCD163 from baseline to week 24.
Measured: Measured at baseline and week 24
Change (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta)
The chemokines macrophage inflammatory protein-1 alpha and beta (MIP-1 alpha and beta, pg/mL) as well as the chemokine, RANTES (ng/mL), are markers of inflammation. Higher value of change means an increase in the biomarker levels over time. Higher levels of these biomarkers indicates inflammation.
RANTES and MIP-1 beta are ligands of CCR5 that were expected to increase with CVC.
The results are expressed as the ratio of RANTES or MIP-1 beta at week 24 to baseline.
Measured: Measured at baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start30 May 2023
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At study entry, participants were randomized 2:1 to oral CVC (Arm A) or oral placebo for CVC (Arm B) once a day. The study treatment was added to the participants' pre-existing antiretroviral treatment (ART) regimens.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- Janet Lo, MD, MMSc, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630885
- Sponsor's protocol ID
- A5415
- Status last verified
- Jun 2025
- First submitted
- 10 Nov 2022
- Last updated
- 16 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be published in a manuscript and supporting information submitted to NHLBI BioData Catalyst® (BDC) (including data dictionaries and case report forms).
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Limited-Center, Prospective, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV
- ClinicalTrials.gov ID
- NCT05630885
- Acronym / sponsor ID
- A5415
- Conditions
- HIV-1-infection, Elevated Cardiovascular Risk
- Keywords
- HIV, Vascular Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- AbbVie
- Study start
- 30 May 2023 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- At study entry, participants were randomized 2:1 to oral CVC (Arm A) or oral placebo for CVC (Arm B) once a day. The study treatment was added to the participants' pre-existing antiretroviral treatment (ART) regimens.
| Arm | Type | Receives |
|---|---|---|
| CVC arm (Arm A) | Experimental | Drug: CVC 150 mg, Drug: CVC 300 mgParticipants with pre-existing ART regimen of efavirenz (EFV) took CVC 300 mg. Participants with all other pre-existing ART regimens took CVC 150 mg. |
| Placebo for CVC arm (Arm B) | Placebo comparator | Other: Placebo for CVC 150 mg, Other: Placebo for CVC 300 mgParticipants with pre-existing ART regimen of efavirenz (EFV) took placebo for CVC 300 mg. Participants with all other pre-existing ART regimens took placebo for CVC 150 mg. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (14 listed)
- Acute coronary syndrome
- A current diagnosis of latent or active tuberculosis (TB) infection
- Current diagnosis with other intracellular pathogens (Mycobacterium avium complex, Listeria monocytogenes, Toxoplasma gondii, and Cryptococcus neoformans).
- Untreated hepatitis B virus (HBV) infection
- Current hepatitis C virus (HCV) infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVC 150 mgAdministered as one 150-mg tablet by mouth once a day with food. | Drug | CVC arm (Arm A) |
| CVC 300 mgAdministered as two 150-mg tablets by mouth once a day with food. | Drug | CVC arm (Arm A) |
| Placebo for CVC 150 mgAdministered as one 150-mg matching placebo tablets by mouth once a day with food. | Other | Placebo for CVC arm (Arm B) |
| Placebo for CVC 300 mgAdministered as two 150-mg matching placebo tablets by mouth once a day with food. | Other | Placebo for CVC arm (Arm B) |
Primary outcome
Change (Expressed as Ratio to Baseline) in 18-FDG-PET Target-to-background Ratio (TBR) of the Most Diseased Segment (MDS) of the Index (Most-inflamed) Vessel.
Time frame: Measured at baseline and week 24
Target-to-Background Ratio (TBR) measures the intensity of inflammation of a target arterial wall (aorta, left carotid, right carotid), relative to its respective blood background. Specifically, it is the ratio of the Standardized Uptake Value (SUV) of 18-FDG-PET in the target vessel to SUV in the blood background. A negative number for the change in TBR means a reduction in the target arterial wall inflammation over time. Index vessel is the vessel with the highest vessel TBR at baseline. The most diseased segment is the approximately 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the ratio of TBR at week 24 to baseline. For the statistical analyses, results for the 6 and 9 missing values in Arm A and Arm B, respectively, were imputed using multiple imputation by regression.
7 secondary outcomes
Change (Expressed as Ratio to Baseline) in Aortic TBR (and Other TBRs)
Time frame: Measured at baseline and week 24
Change (Expressed as Ratio to Baseline) in Standardized Uptake Value (SUV) Measured in the Carotid Arteries and Aorta
Time frame: Measured at baseline and week 24
Change in Fasting Glucose
Time frame: Measured at baseline and week 24
Change (Expressed as Ratio to Baseline) in Fasting Insulin and Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)
Time frame: Measured at baseline and week 24
Change (Expressed as Ratio to Baseline) in Biomarkers of Inflammation (IL-6, hsCRP, and MCP-1)
Time frame: Measured at baseline and week 24
Change in Biomarkers of Immune Activation (sCD14 and sCD163)
Time frame: Measured at baseline and week 24
Change (Expressed as Ratio to Baseline) in Plasma Levels of Chemokine Receptor 5 (CCR5) Ligands (RANTES and MIP-1 Beta)
Time frame: Measured at baseline and week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Specific table used in the study protocol. For example, "The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009)."Link provided by the sponsor.
- Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Results will be published in a manuscript and supporting information submitted to NHLBI BioData Catalyst® (BDC) (including data dictionaries and case report forms).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Lo, MD, MMSc study chair
Massachusetts General Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CVC 150 mg and CVC 300 mg in people with HIV-1-infection and Elevated Cardiovascular Risk, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (Expressed as Ratio to Baseline) in 18-FDG-PET Target-to-background Ratio (TBR) of the Most Diseased Segment (MDS) of the Index (Most-inflamed) Vessel. (time frame: Measured at baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.