A5415: A Limited-Center, Prospective, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living with HIV

Treatment Experienced

People with HIV can have an increase in inflammation in their body organs even after taking anti-HIV medicines (ART, or antiretroviral therapy). Chronic HIV infection has been associated with a state of systemic inflammation and immune activation, thus increasing the incidence of heart disease and death from heart disease. HIV researchers are studying the harmful effects of this long-term inflammation and possible ways to prevent these complications.

 

The A5415 study is being conducted to investigate the effects of cenicriviroc (CVC) on arterial inflammation in individuals with HIV on stable suppressive ART. CVC is a medication being developed as a treatment for HIV and being studied as a possible drug to decrease blood vessel inflammation and plaque formation in the setting of chronic infection.

• To learn about the effects of CVC on inflammation and heart health in people with HIV.
• To learn if CVC can lower blood vessel inflammation by looking at the carotid arteries (arteries in your neck) and the aorta (the main artery in your body) through a test called an FDG-PET/CT (18F-fluorodeoxyglucose-positron emission tomography/computed tomography).

• People with HIV
• At least 45 years of age
• On continuous anti-HIV medications with undetectable HIV viral load for at least 48 weeks
• On NNRTI-based or unboosted INSTI-based ART regimen
• Have no active heart disease including heart attack, but are at increased risk for heart disease
• CD4 count greater than 200
• No active hepatitis B or C
• No history of radiation therapy
• Not pregnant or breastfeeding

Participants will be randomized 2:1 to receive either cenicriviroc or a placebo (sugar pill) by mouth once daily, added to their current anti-HIV regimen. Participants in the study will be on study treatment and followed on study for 24 weeks. An FDG-PET/CT scan will be done before starting study drug and at study week 24.

Cenicriviroc will be provided by the study.

24 weeks