Investigator Studies Program (MISP): Letermovir
Effective November 2018, the CMV Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to March 1, 2019 for the first review cycle, and up to August 9, 2019 for the second review cycle. This is a competitive process that will be conducted by the CMV MISP in 2019. Decisions will be made based on scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below.
The following areas are of interest to Investigator Studies Program Committee
- Observational studies in specific HSCT patient populations (e.g., cord blood transplant, haplo, HLA- mismatch, etc.) and solid organ transplant (SOT) recipients in different global geographic regions describing unmet needs in the prevention of CMV, including but not limited to:
- Disease and economic/health care utilization burden.
- Impact of CMV infection/reactivation on organ and patient outcomes.
- Impact of letermovir prophylaxis on disease and economic/health care utilization burden within label indication.
- Limitations or prophylaxis with DNA polymerase inhibitors.
- Novel methods to identify or define cases of antiviral toxicity.
- Studies aimed at biomarkers or other testing to evaluate the host and/or viral response to letermovir, and that may elucidate the pathology or early CMV reactivation
- Understanding the terminase inhibitor mechanism of action including but not limited to the impact on viral dynamics DNA polymerase/thymidine kinase inhibitor agents, potential new viral markers for functional DNA, and the impact on the host immune response to CMV (improved understanding of the naked capsid effects on the host immune system)
- Further understanding the mechanisms and occurrence of resistance to letermovir (including understanding of the impact of genotype with phenotype; the impact of resistance patterns to letermovir and anti-CMV agents either together or separately and viral fitness) and how may these be overcome
- Studies characterizing the impact of letermovir on populations other than HSCT and SOT (e.g., HIV, elderly/immunosenecent, etc.)
- Studies to optimize prophylaxis strategies in immunocompromised patients (for example but not limited to):
- Timing of initiation of prophylaxis in the alloHSCT population
- Utilization of immunologic markers to guide initiation and duration of prophylaxis
Please complete a full protocol and detailed budget via Visiontracker
, the Company's on-line study management system (in US) or your MSD country representative (outside US). The proposals will be collectively reviewed and selected by the CMV MISP Committee.
Critical Activities and Timelines:
||1st Review Cycle
||2nd Review Cycle
|Full Protocol Submission with Detailed Budget
||March 1, 2019
||August 9, 2019
|MISP-RC Review Meeting
||April 2, 2019
||September 19, 2019
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator
Studies Program should contact their local MSD office