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NCT05362916: Letermovir
Letermovir in ART-treated HIV-infected Persons
NA trial testing Letermovir in People Living With HIV in 33 participants. Completed in 27 January 2025.
27 January 2025
Quick facts
| Lead sponsor | Jean-Pierre Routy |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 26 September 2022 |
| Primary completion | 27 January 2025 |
| Estimated completion | 27 January 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Letermovir (LETERMOVIR) — full drug profile →
Conditions studied
- People Living With HIV — all drugs for People Living With HIV →
Sponsor
Jean-Pierre Routy
Who can join
Adults 18 to 99, any sex, with People Living With HIV. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Influence of letermovir treatment on gut inflammation in people living with HIV on antiretroviral therapy: protocol of the open-label controlled randomised CIAO study.
Royston L, Isnard S, Berini CA, Bu S, et al · · 2023 · cited 2× · PMID 36690406 · DOI 10.1136/bmjopen-2022-067640
Verify or expand the search:
- PubMed search for NCT05362916
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Letermovir
Trials testing the same drug.
- NCT07020533 — A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Pa · Phase 1 · recruiting
- NCT07199465 — A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077) · Phase 1 · recruiting
- NCT07488728 — Letermovir Prophylaxis in Children With EBV-Positive T/NK-Cell Lymphoproliferative Disease and Refractory/Relapsed EBV-A · NA · recruiting
- NCT07079735 — Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant · Phase 2, PHASE3 · recruiting
- NCT06920251 — Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy · Phase 2 · recruiting
Other recruiting trials for People Living With HIV
Currently open trials in the same condition.
- NCT05958017 — reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA) · NA · recruiting
- NCT06599658 — COVID-19 Booster and IIV Schedule in Immunocompromised Hosts · Phase 2 · recruiting
- NCT05123144 — A Hybrid Type II Trial of the Optimizing Resilience and Coping With HIV Through Internet Delivery in Ryan White Clinics · Phase 2 · active not recruiting
Other Jean-Pierre Routy trials
Trials by the same sponsor.
- NCT06022406 — Fecal Microbiota Translantation (FMT) to Reduce Inflammation in PLWH: The Gutsy Pilot Study · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05362916 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jean-Pierre Routy
- Last refreshed: 31 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05362916.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing