A5383: Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)

HIV comorbidities and complications

This study will include 180 participants. Participants will have HIV and Cytomegalovirus (CMV). CMV is common virus that many people living with and without HIV have been exposed to. You do not need to know if you have CMV to be considered for study participation. About half of the study participants will be given study medication to be taken once daily for 48 weeks. The study medication will be letermovir, an FDA approved medication to prevent CMV. The other half of
participants will not receive any additional medication. The study will last about 1 year and 2 months.

To learn whether people living with well controlled HIV and symptom free CMV can reduce inflammation by taking a drug approved by the FDA to prevent CMV disease.

To Enter the Study, the following must be true about you:

• HIV positive, ≥40 years of age
• On continuous anti-HIV medications for at least 48 months with no interruptions >7 days
• At least 48 months of undetectable viral loads, although a one-time, low-level viral load is OK
• Have not made significant change in HIV medication in the past 12 weeks, or plan to make changes during study participation
• No heart arrythmias/ irregular heart beats
• No active Hepatitis B or hepatitis C within 24 weeks
• Not currently using any of the following HIV medications: efavirenz, nevirapine, etravirine, lopinavir/ritonavir, or once a day dosing of raltegravir (twice a day dosing is OK)
• While people with any CD4 count are eligible, the study is particularly interested in recruiting people with low CD4 counts (i.e., <350 cells/mm3)
• While people of all gender identities are eligible, the study is particularly interested in recruiting cis-gender women and transgender women receiving gender-affirming hormones

There will be treatment provided in this study. Letermovir is a pill given by mouth once a day that is FDA-approved to prevent CMV disease. There are two study treatment groups.
You will have a 50/50 chance of going into one of the two groups. Participants in one group will get letermovir and participants in the other group will not get any additional medications.