This is a multi-centre, open-label, randomized, controlled clinical trial to assess the
influence of letermovir on gut translocation marker LPS in blood in ART-treated
cytomegalovirus (CMV)-seropositive adult people living with HIV (PLWH). The study will
explore the influence of letermovir treatment on gut damage, with no intention for label
change. Participants (n=60) should have a cluster of differentiation 4 cells (CD4) count
greater than 400 cells/µl and a negative viral load. Forty (40) participants will be
randomized to receive letermovir (PREVYMIS® 480 mg or 2x240mg orally) in addition to their
usual ART, and 20 participants will receive standard of care alone (ART only) for 14 weeks.
Study visits will include screening, 2 baselines, followed by follow-up visits at 2 and 4
weeks and at 14 weeks after starting treatment and 12 weeks after end of letermovir treatment
to assess a carry-over effect.
In an optional sub-study, colonoscopies and colon biopsies will be performed before and after
letermovir treatment or standard of care alone to assess gut mucosa inflammation.