Letermovir in ART-treated HIV-infected Persons

Summary

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.

Timeline

Start

2022-09-26

Primary completion

2025-01-27

Completion

2025-01-27

Publications

• Royston L, Isnard S, Berini CA, Bu S, Lakatos PL, Bessissow T, Chomont N, Klein M, Lebouche B, de Pokomandy A, Kronfli N, Costiniuk CT, Thomas R, Tremblay C, Boivin G, Routy JP. Influence of letermovir treatment on gut inflammation in people living with HIV on antiretroviral therapy: protocol of the open-label controlled randomised CIAO study. BMJ Open. 2023 Jan 23;13(1):e067640. doi: 10.1136/bmjopen-2022-067640.

Drugs

Indications

No indication recorded.