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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


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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