CMV ViremiaPhase 2/3VALET-CMVNCT07079735
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
A Phase 2/3 study testing Letermovir and Valganciclovir in people with CMV Viremia and Heart Transplant Infection, run by Columbia University at 2 sites in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of letermovir with valganciclovir for prevention of Cytomegalovirus (CMV) viremia in moderate to high risk serostatus heart transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- CMV Viremia, Heart Transplant Infection, Heart Transplant Failure and Rejection
- What is being tested?
- Letermovir and Valganciclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Sep 2025to 17 Jan 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are >18 years of age who have received a heart transplant and have not started their CMV prophylaxis regimen will be included.
Who cannot join
- History of or suspected CMV disease within 6 months prior is excluded.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Adel T Alnatour, BS contact
United States2 sites, 2 recruiting
- Recruiting
NYP-Weill Cornell
New York, New York, 10021
David Majure, MD, 6469629062, dtm9002@med.cornell.edu
Adel T Alnatour, BS
- Recruiting
Columbia University/NYP Milstein Hospital
New York, New York, 10032
Afsana Rahman, MD, 2123054600, ar3262@cumc.columbia.edu
Adel T Alnatour, BS
About this study
Official title: VALganciclovir vs. LETermovir for Primary Prevention of CMV in Moderate to High-Risk Heart Transplant Recipients (The VALET-CMV Study)
The purpose of this study is to compare the safety and efficacy of letermovir with valganciclovir for prevention of Cytomegalovirus (CMV) viremia in moderate to high risk serostatus heart transplant recipients.
Read the detailed description
This trial is a multi-center prospective, two-arm randomized study designed to assess the safety of letermovir use as the primary prophylaxis for CMV in patients recently transplanted with a heart. Although there are findings to support the safety and efficacy profiles of letermovir in certain patient populations (kidney transplant, lung transplant, and hematopoetic stem cell transplant), there is a clear lack of prospective data to support use of letermovir at the primary prevention of CMV for patients recently transplanted with a heart. Thus, despite numerous studies showing letermovir to be non-inferior to valganciclovir with a substantial reduction in leukopenia and neutropenia, valganciclovir continues to be the initial CMV prophylaxis in heart transplant recipients. This study aims to either confirm the findings about letermovir as seen in other patient populations, or to highlight potential concerns about using letermovir in heart transplant patients. Patients who get letermovir will also be given acyclovir for HSV (Herpes Simplex Virus) prophylaxis for 6 months. Those taking valganciclovir will not need this as HSV is covered by valganciclovir. Low risk patients will also be monitored during this period for a better understanding of CMV disease in this population.
- Being tested
- Letermovir, Valganciclovir
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
CMV prophylaxis
ValganciclovirDrug
Standard therapy for CMV prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| Letermovir | Experimental | Patients with moderate to high risk CMV risk will get letermovir for prophylaxis for 6 months for moderate risk and 1 year for high risk Receives: Drug: Letermovir |
| Valganciclovir | Active comparator | Patients with moderate to high risk CMV risk will get valganciclovir for prophylaxis for 6 months for moderate risk and 1 year for high risk. This is standard of care Receives: Drug: Valganciclovir |
| No treatment | No intervention | Low risk CMV patients who do not have an indication for CMV prophylaxis will be monitored |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of leukopenia
Number of patients with leukopenia (white blood cell count <3000 cells µL)
Measured: During the duration of CMV prophylaxis (6 months for moderate risk and 12 months for high risk from start of therapy)
Occurrence of neutropenia
Number of patients with neutropenia (absolute neutrophil count <1500 cells/µL)
Measured: During the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk from start of therapy)
Secondary outcomes (3)
Number of patients with any detectable CMV viremia after initiation of CMV prophylaxis
Number of patients with any positive CMV viral load detected by polymerase chain reaction (PCR)
Measured: 6 months after initiation of CMV prophylaxis
Number of patients with any detectable CMV viremia while on CMV prophylaxis
Number of patients with any positive CMV viral load detected by PCR.
Measured: During the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk patients)
Number of patients with any detectable CMV viremia after completing CMV prophylaxis
Number of patients with any positive CMV viral load detected by PCR.
Measured: Within 6 months after completing CMV prophylaxis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start12 Sep 2025
- Primary completion17 Jan 2028 (estimated)
- Study completion17 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CMV ViremiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University
- Responsible party
- Principal investigator, Afsana Rahman, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079735
- Sponsor's protocol ID
- AAAV8422
- Acronym
- VALET-CMV
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.
PubMed 37279999Chong PP, Teiber D, Prokesch BC, Arasaratnam RJ, Peltz M, Drazner MH, Garg S. Letermovir successfully used for secondary prophylaxis in a heart transplant recipient with ganciclovir-resistant cytomegalovirus syndrome (UL97 mutation). Transpl Infect Dis. 2018 Oct;20(5):e12965. doi: 10.1111/tid.12965. Epub 2018 Jul 20.
PubMed 29989279Saullo JL, Miller RA. Cytomegalovirus Therapy: Role of Letermovir in Prophylaxis and Treatment in Transplant Recipients. Annu Rev Med. 2023 Jan 27;74:89-105. doi: 10.1146/annurev-med-042921-124739. Epub 2022 Nov 4.
PubMed 36332639Potena L, Solidoro P, Patrucco F, Borgese L. Treatment and prevention of cytomegalovirus infection in heart and lung transplantation: an update. Expert Opin Pharmacother. 2016 Aug;17(12):1611-22. doi: 10.1080/14656566.2016.1199684. Epub 2016 Jun 30.
PubMed 27340928Saullo JL, Baker AW, Snyder LD, Reynolds JM, Zaffiri L, Eichenberger EM, Ferrari A, Steinbrink JM, Maziarz EK, Bacchus M, Berry H, Kakoullis SA, Wolfe CR. Cytomegalovirus prevention in thoracic organ transplantation: A single-center evaluation of letermovir prophylaxis. J Heart Lung Transplant. 2022 Apr;41(4):508-515. doi: 10.1016/j.healun.2021.12.005. Epub 2021 Dec 22.
PubMed 35031206Rahman A, Lee C, Rahman S, Baranowska J, Moeller CM, Valledor AF, Rubenstein G, Oren D, Alnatour AT, Labarre B, Taek K, Bae D, Raikhelkar J, Lotan D, Defilippis EM, Yunis AA, Fried J, Latif F, Yuzefpolskaya M, Colombo PC, Lin E, Majure DT, Clerkin KJ, Choe J, Sayer G, Uriel N. Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Heart Transplant Recipients with Moderate to High-Risk CMV Serostatus. J Card Fail. 2026 Jul;32(7):1144-1150. doi: 10.1016/j.cardfail.2025.05.017. Epub 2025 Jun 23.
PubMed 40562091
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VALganciclovir vs. LETermovir for Primary Prevention of CMV in Moderate to High-Risk Heart Transplant Recipients (The VALET-CMV Study)
- ClinicalTrials.gov ID
- NCT07079735
- Acronym / sponsor ID
- VALET-CMV / AAAV8422
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Cornell University
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 17 Jan 2028 (estimated)
- Study completion
- 17 Jan 2029 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and efficacy of letermovir with valganciclovir for prevention of Cytomegalovirus (CMV) viremia in moderate to high risk serostatus heart transplant recipients.
Detailed description
This trial is a multi-center prospective, two-arm randomized study designed to assess the safety of letermovir use as the primary prophylaxis for CMV in patients recently transplanted with a heart. Although there are findings to support the safety and efficacy profiles of letermovir in certain patient populations (kidney transplant, lung transplant, and hematopoetic stem cell transplant), there is a clear lack of prospective data to support use of letermovir at the primary prevention of CMV for patients recently transplanted with a heart. Thus, despite numerous studies showing letermovir to be non-inferior to valganciclovir with a substantial reduction in leukopenia and neutropenia, valganciclovir continues to be the initial CMV prophylaxis in heart transplant recipients. This study aims to either confirm the findings about letermovir as seen in other patient populations, or to highlight potential concerns about using letermovir in heart transplant patients. Patients who get letermovir will also be given acyclovir for HSV (Herpes Simplex Virus) prophylaxis for 6 months. Those taking valganciclovir will not need this as HSV is covered by valganciclovir. Low risk patients will also be monitored during this period for a better understanding of CMV disease in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Letermovir | Experimental | Drug: LetermovirPatients with moderate to high risk CMV risk will get letermovir for prophylaxis for 6 months for moderate risk and 1 year for high risk |
| Valganciclovir | Active comparator | Drug: ValganciclovirPatients with moderate to high risk CMV risk will get valganciclovir for prophylaxis for 6 months for moderate risk and 1 year for high risk. This is standard of care |
| No treatment | No intervention | –Low risk CMV patients who do not have an indication for CMV prophylaxis will be monitored |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are >18 years of age who have received a heart transplant and have not started their CMV prophylaxis regimen will be included.
Key exclusion criteria (1 listed)
- History of or suspected CMV disease within 6 months prior is excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetermovirCMV prophylaxis | Drug | Letermovir |
| ValganciclovirStandard therapy for CMV prophylaxis | Drug | Valganciclovir |
Primary outcome
Occurrence of leukopenia
Time frame: During the duration of CMV prophylaxis (6 months for moderate risk and 12 months for high risk from start of therapy)
Number of patients with leukopenia (white blood cell count <3000 cells µL)
Occurrence of neutropenia
Time frame: During the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk from start of therapy)
Number of patients with neutropenia (absolute neutrophil count <1500 cells/µL)
3 secondary outcomes
Number of patients with any detectable CMV viremia after initiation of CMV prophylaxis
Time frame: 6 months after initiation of CMV prophylaxis
Number of patients with any detectable CMV viremia while on CMV prophylaxis
Time frame: During the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk patients)
Number of patients with any detectable CMV viremia after completing CMV prophylaxis
Time frame: Within 6 months after completing CMV prophylaxis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 37279999Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.
- Background: PubMed 29989279Chong PP, Teiber D, Prokesch BC, Arasaratnam RJ, Peltz M, Drazner MH, Garg S. Letermovir successfully used for secondary prophylaxis in a heart transplant recipient with ganciclovir-resistant cytomegalovirus syndrome (UL97 mutation). Transpl Infect Dis. 2018 Oct;20(5):e12965. doi: 10.1111/tid.12965. Epub 2018 Jul 20.
- Background: PubMed 36332639Saullo JL, Miller RA. Cytomegalovirus Therapy: Role of Letermovir in Prophylaxis and Treatment in Transplant Recipients. Annu Rev Med. 2023 Jan 27;74:89-105. doi: 10.1146/annurev-med-042921-124739. Epub 2022 Nov 4.
- Background: PubMed 27340928Potena L, Solidoro P, Patrucco F, Borgese L. Treatment and prevention of cytomegalovirus infection in heart and lung transplantation: an update. Expert Opin Pharmacother. 2016 Aug;17(12):1611-22. doi: 10.1080/14656566.2016.1199684. Epub 2016 Jun 30.
- Background: PubMed 35031206Saullo JL, Baker AW, Snyder LD, Reynolds JM, Zaffiri L, Eichenberger EM, Ferrari A, Steinbrink JM, Maziarz EK, Bacchus M, Berry H, Kakoullis SA, Wolfe CR. Cytomegalovirus prevention in thoracic organ transplantation: A single-center evaluation of letermovir prophylaxis. J Heart Lung Transplant. 2022 Apr;41(4):508-515. doi: 10.1016/j.healun.2021.12.005. Epub 2021 Dec 22.
- Background: PubMed 40562091Rahman A, Lee C, Rahman S, Baranowska J, Moeller CM, Valledor AF, Rubenstein G, Oren D, Alnatour AT, Labarre B, Taek K, Bae D, Raikhelkar J, Lotan D, Defilippis EM, Yunis AA, Fried J, Latif F, Yuzefpolskaya M, Colombo PC, Lin E, Majure DT, Clerkin KJ, Choe J, Sayer G, Uriel N. Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Heart Transplant Recipients with Moderate to High-Risk CMV Serostatus. J Card Fail. 2026 Jul;32(7):1144-1150. doi: 10.1016/j.cardfail.2025.05.017. Epub 2025 Jun 23.
- Individual participant dataSharing planned: No
Related trials for CMV Viremia
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Active, not recruitingPhase 1
CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant
Accelerated Phase CML, BCR-ABL1 Positive, Acute Lymphoblastic Leukemia in Remission
RecruitingPhase 3
Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone
CMV, AdV Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adel T Alnatour, BS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Letermovir and Valganciclovir in people with CMV Viremia and Heart Transplant Infection, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Afsana Rahman, MD (2123054600, ar3262@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of leukopenia (time frame: During the duration of CMV prophylaxis (6 months for moderate risk and 12 months for high risk from start of therapy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07079735, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.