A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis)

Status Completed

Clinical Trial Summary

This is an open-label, controlled study, conducted at US sites to evaluate the anti-inflammatory effectiveness of the study drug letermovir in adults with HIV and asymptomatic cytomegalovirus (CMV) who are on antiretroviral therapy (ART)-mediated suppression. Participants will be randomly assigned to receive either letermovir once daily or no anti-CMV treatment, for 48 weeks.

Clinical Trial Description

This is a phase 2, randomized, open-label, controlled, multicenter trial to evaluate the anti-inflammatory efficacy of letermovir, administered once daily for 48 weeks in adults with HIV and asymptomatic CMV, who are on ART-mediated suppression. Participants will be randomized 1:1 to receive either letermovir or no anti-CMV treatment. A futility analysis will be performed after the first 40 participants to initiate study treatment reach their 8-week study visit. Study enrollment will be paused after the 40th participant starts treatment until the results of the futility analysis have been considered. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04840199
Study type	Interventional
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status	Completed
Phase	Phase 2
Start date	November 2, 2022
Completion date	November 30, 2023

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