Official Title

A5383, Randomized, Controlled Trial to Evaluate the Antiinflammatory 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)

Purpose

The purpose of this study is to evaluate whether letermovir (Prevymis), taken as two 240 mg tablets (480 mg total) or one 480 mg tablet once daily for 48 weeks, reduces inflammation in adults with human immunodeficiency virus (HIV-1) who also have cytomegalovirus (CMV) without any symptoms and who have been on effective anti-HIV medication for at least one year. Reducing inflammation might in turn help prevent some longer-term consequences of HIV, like heart disease and diabetes. This study will also look at whether you experience any side effects to the study drug. The study will last for about 1 year and 2 months (about 11 months on either letermovir or no anti-CMV study reatment and then about another 3 months of follow-up).

Could this study be right for you?

• HIV and CMV antibody positive •greater than or equal to 40 years of age • Not currently using any of the following ART medications: efavirenz, nevirapine, etravirine, lopinavir/ritonavir, or once a day dosing of raltegravir (twice daily OK) • Not pregnant or breastfeeding or planning to become pregnant during the study • No use of anti-CMV drugs within 90 days prior to study participation • No active HCV or HBV in past 24 weeks No presence or history of atrial or ventricular tachycardias • All gender identities are eligible, but there are enrollment targets for cis-women or transgender women on gender-affirming hormones

Age Range

40 and up