THE CVC STUDY

We are looking for people with HIV over 45 years old who are undetectable and who have at least one cardiovascular risk factor

WHO: People with HIV (PWH) at least 45 years old on a stable NNRTI-based or unboosted INSTI-based regimen who is undetectable for at least 48 weeks with at least one cardiovascular risk factor:

Clinical atherosclerotic disease
Subclinical atherosclerotic disease
Diabetes mellitus (DM) or prediabetes or impaired fasting glucose or insulin resistance
Obesity or enlarged iliac waist circumference
History of hypertension or blood pressure ≥130/80 mmHg
Elevated low-density lipoprotein (LDL) cholesterol
Low high-density lipoprotein (HDL) cholesterol
Smoking (any current tobacco smoking)
Family history of premature coronary artery disease (CAD; first degree relative with CAD prior to age 55 for male relative and 65 for female relative)
High sensitivity C-reactive protein (hsCRP) >2.0 mg/L

WHAT: Randomized (like flipping a coin) to take cenicriviroc mesylate (CVC) or placebo by mouth once a day for 24 weeks in addition to the participant’s pre-existing HIV regimen

WHY: To see whether CVC treatment reduce inflammation of the arteries (the blood vessels that carry blood from the heart through the body) in people with HIV

HOW LONG: about 24 weeks

HOW: Exams, blood draws, urine collection, food diary at week 22, FDG-PET/CT imaging

MAIN REQUIREMENTS

People with HIV at least 45 years old on a stable NNRTI-based or unboosted INSTI-based regimen
Undetectable for at least 48 weeks
At least one of the following cardiovascular risk factors:
- Clinical atherosclerotic disease
- Subclinical atherosclerotic disease
- Diabetes mellitus (DM) or prediabetes or impaired fasting glucose or insulin resistance
- Obesity or enlarged iliac waist circumference
- History of hypertension or blood pressure ≥130/80 mmHg
- Elevated low-density lipoprotein (LDL) cholesterol
- Low high-density lipoprotein (HDL) cholesterol
- Smoking (any current tobacco smoking)
- Family history of premature coronary artery disease (CAD; first degree relative with CAD prior to age 55 for male relative and 65 for female relative)
- High sensitivity C-reactive protein (hsCRP) >2.0 mg/L
Pre-entry FDG-PET/CT imaging (within 60 days prior to study entry)
Not pregnant nor breastfeeding, nor planning to become pregnant during the length of the study and three months after completing the study
Willingness to use two forms of contraception while receiving study medication and for 3 months after stopping study medication
No myocardial infarction (MI) or unstable angina, within 90 days prior to study entry
No latent or active tuberculosis (TB)
No untreated hepatitis B virus (HBV) within 6 months
No Current hepatitis C virus (HCV) (people with successfully treated HCV for at least 6 months are allowed
No acute infection or illness requiring IV antibiotics or hospitalization within 90 days prior to study entry
No liver disease or cancer
No current use of any of the statins at the doses indicated:
- Atorvastatin, >40 mg/day dose
- Rosuvastatin, ≥20 mg/day dose
No addition of any lipid lowering medication during the course of the study
No use of drugs with potential drug-drug interactions with CVC within 90 days prior to study entry
No Known allergy/sensitivity to components of study drug(s) or their formulation
No treatment within 30 days prior to study entry or anticipated treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons, cyclosporine, and tacrolimus).
No Immunization within 7 days prior to the pre-entry FDG-PET/CT imaging
No history of radiation therapy, nor high radiation exposure within one year prior to entry
Body weight less than 300 lbs
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

ABOUT THIS STUDY

The chances of cardiovascular disease (CVD) are increased among people living with HIV, with traditional risk factors, like diabetes, excess abdominal fat, and smoking being very common. Furthermore, activation of the innate immune system and increased inflammation are likely to contribute to increased cardiovascular risk in people who have been living with HIV for a long time.

Cenicriviroc mesylate (CVC) is an investigational drug that was initially developed as an anti-HIV drug that has since been used to treat liver disease. We believe CVC treatment will reduce inflammation of the arteries and throughout the body in PWH.

Participants will be randomized (like flipping a coin) 2 to 1 to take CVC or placebo by mouth once a day for 24 weeks in addition to their pre-existing HIV regimen.

Participants will required to have a FDG-PET/CT scans that will show differences between healthy tissue and diseased tissues at the pre-entry and week 24 visits.

There is also a very small possibility that the scan may be repeated if one of these two scans could not be evaluated. At most the scan will only be repeated one extra time.

Length of study: about 24 weeks

Reducing Inflammation in People with HIV

Here is a recording of our community meeting where we discussed the health concerns of people with HIV when it comes to the chronic inflammation that comes from living with the virus and how the CVC Study (ACTG 5415) may help us come up with a treatment to reduce the consequences of that inflammation.