Letermovir for HIV
(Letermovir Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called letermovir (Prevymis) to see if it can reduce gut damage in people with HIV who also have cytomegalovirus (CMV), a common virus. Researchers aim to determine if adding letermovir to standard HIV treatment can lower specific blood markers indicating gut issues. Participants should have stable HIV treatment, a healthy level of immune cells (CD4 count over 400), and a negative viral load, meaning the virus is undetectable in their blood. The trial includes a group receiving letermovir and a control group continuing with their usual treatment. Some participants may undergo optional procedures to check for gut inflammation. As an unphased trial, this study offers the chance to contribute to important research that could improve future treatments for people with HIV and CMV.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot use certain drugs that interact with letermovir, like pimozide or certain statins. If you're on statins, the dose will be reduced by 50% during the study. Some HIV medications like darunavir, efavirenz, etravirine, and nevirapine are also not allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that letermovir is generally safe and well tolerated. In earlier studies, some participants experienced mild side effects, such as diarrhea and headaches. Importantly, no serious health problems were reported. Letermovir is already approved for preventing CMV, a common virus, in certain patients, suggesting a strong safety record. While the treatment remains under study, current evidence indicates it is safe for humans.12345
Why are researchers excited about this trial?
Letermovir is unique because, unlike standard treatments for cytomegalovirus (CMV) infections in HIV patients, which often include antiviral medications like ganciclovir, foscarnet, or cidofovir, it specifically targets the CMV DNA terminase complex. This different mechanism of action could potentially offer a more targeted approach to managing CMV without the broader side effects associated with traditional antivirals. Researchers are excited about Letermovir as it may provide a safer, more effective option for patients with HIV who are also battling CMV infections.
What evidence suggests that letermovir might be an effective treatment for gut damage in people living with HIV?
This trial will evaluate the effects of Letermovir on patients with HIV. Studies have shown that Letermovir can help reduce inflammation in people living with HIV. Research indicates that while Letermovir might initially increase some signs of inflammation, it eventually leads to lasting reductions. Importantly, it has improved immune function by increasing CD4 cell counts, crucial for a healthy immune system. Letermovir has also lowered the risk of serious cytomegalovirus (CMV) issues, a concern for those with HIV. These promising results suggest Letermovir could help manage inflammation and boost immune health in HIV patients. In this trial, 40 patients with CMV infection will receive Letermovir, while 20 patients will serve as controls and will not receive the treatment.12567
Who Is on the Research Team?
Carolina A Berini, BSc, PhD
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Are You a Good Fit for This Trial?
Adults over 18 with HIV, on stable ART for at least 3 years, and a viral load under control. They must be CMV seropositive with CD4 counts above 400 cells/µl. Participants should not have severe liver or kidney issues, allergies to letermovir, uncontrolled diseases like high blood pressure or active infections including COVID-19. Pregnant women and those on certain drugs are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo baseline assessments before starting treatment
Treatment
Participants receive letermovir in addition to ART or standard of care alone for 14 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a visit 12 weeks after the end of letermovir treatment
Optional Sub-study
Participants may opt into a sub-study involving colonoscopies and colon biopsies to assess gut mucosa inflammation
What Are the Treatments Tested in This Trial?
Interventions
- Letermovir
Letermovir is already approved in United States, European Union for the following indications:
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Prophylaxis of cytomegalovirus (CMV) disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
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Who Is Running the Clinical Trial?
Jean-Pierre Routy
Lead Sponsor