A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.
Summary
This was 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 were on antiretroviral therapy (ART)-mediated suppression. Participants were randomly assigned to receive either letermovir once daily or no anti-CMV treatment, for 48 weeks. The primary hypothesis of this study was that letermovir would cause a greater reduction in plasma soluble receptor for tumor necrosis factor type II (sTNFRII) levels than no anti-CMV treatment at weeks 46/48.
Timeline
- Start
- 2022-04-19
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
Outcome
Missed primary endpoint
Stopped (Enrollment): “Permanently closed to screening and accrual due to futility”
registry analysis (superiority test); Letermovir vs No Anti-CMV Treatment; p = 0.20; Mean Difference (Net) -0.031 (95% CI -0.080 to 0.018); NCT04840199 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Letermovir | Small molecule | 480 mg | Oral |