The ELICIT Study

 

FOR ALL PEOPLE WITH HIV AND CYTOMEGALOVIRUS (CMV)

UW POSITIVE RESEARCH is looking for people with HIV, 18 years of age and older, with a positive blood test for CMV who have been undetectable for one year (“blips” or small increases in viral load that quickly return to undetectable levels are allowed) to see if letermovir reduces inflammation and reduces risk for heart disease, diabetes and other age-related complications.

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ABOUT THIS STUDY

CMV is a very common virus that affects the majority of adults and over 90% of people with HIV. Most healthy people that have CMV have no symptoms at all, but carry the virus in the body their entire life. A large part of the body’s immune defenses is actually devoted to keeping CMV from replicating.

For people with HIV, it is possible that the immune system may not recover to 100% strength during HIV treatment, allowing low-level CMV replication to occur in the body.

Since CMV tends to replicate in the walls of blood vessels and in fat tissue, it can possibly cause inflammation in those places, which may predispose people to heart disease or diabetes, conditions that appear to be increased in people with HIV.

This is why we think that treating low-level CMV might reduce inflammation in people with HIV who are otherwise doing well on HIV medications, and reduce their risk for heart disease, diabetes, and other aging-related complications.

The purpose of this study is to see if letermovir (brand name: Prevymis), a recently FDA-approved medication that blocks CMV replication (meaning the process by which CMV makes copies of itself), reduces inflammation in people with HIV and CMV.

Participants will be randomly assigned (flip of a coin) to take letermovir or placebo once daily for 48 weeks and followed for a total of 60 weeks.

Participants will receive $20 for every visit starting at the screening visit,

EXAMS, TESTS AND THE STUDY MEDICINE ARE ALL PROVIDED AT NO COST

REQUIREMENTS

  •  18 years of age or older with HIV

  •  Positive for CMV exposure on a blood test

  •  On ART with no changes in your medications within 90 days prior to the start of the study

  •  Undetectable HIV viral load for 48 weeks prior to the start of the study (“blips” or small increases in viral load that quickly return to undetectable levels are allowed)

  •  People of reproductive potential must agree to use contraception throughout the study

  •  No use of drugs with anti-CMV activity within 90 days prior to study entry

  •  No acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to entry

  •  No presence or history of conditions that could account for impaired neuropsychological performance

  •  No regular use of addictive, psychoactive drugs (excluding alcohol, nicotine, and cannabis)

 
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UNDERSTANDING THE ELICIT STUDY

During a recent community meeting, Dr. Elizabeth Duke talked to us about treating asymptomatic CMV in people with HIV as a way to treat inflammation that leads to heart disease and diabetes and as a means of lessening the HIV reservoir. She explained The ELICIT Study, and answered the questions from our CAB members.