Letermovir for HIV

(Letermovir Trial)

Overseen By Lena Royston, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jean-Pierre Routy

Must be taking: Antiretrovirals

Must not be taking: Immune-modulators, Antibiotics, PPIs, others

Disqualifiers: AIDS, Hepatitis B/C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 14 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if adding letermovir to regular HIV treatment can reduce gut damage and inflammation in adults with HIV who also have CMV. Letermovir stops the CMV virus from multiplying, which might help improve gut health and reduce related health problems.

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.

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

Documented HIV-1 infection by Western Blot, Enzyme Immuno Assay (EIA) or viral load assay

Women of non-child-bearing potential as defined

CD4 count >400 cells/µL of blood

Exclusion Criteria

I do not have severe illnesses like uncontrolled high blood pressure or kidney failure, nor do I have an active COVID-19 infection.

I have used immune-modulators, antibiotics, acid reducers, Metformin, or Morphine in the last 3 months.

I have not had AIDS-related health issues or serious infections in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants undergo baseline assessments before starting treatment

1 week

2 visits (in-person)

Treatment

Participants receive letermovir in addition to ART or standard of care alone for 14 weeks

14 weeks

3 visits (in-person) at 2, 4, and 14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a visit 12 weeks after the end of letermovir treatment

12 weeks

1 visit (in-person)

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

Trial Overview The trial is testing if Letermovir can reduce gut damage in people living with HIV by looking at the marker LPS in blood. It's an open-label study where participants either add Letermovir to their usual ART or continue with ART alone for comparison.

How Is the Trial Designed?

Group I: Letermovir Experimental Treatment 1 Intervention

40 patients with CMV infection will be treated with Letermovir

Group II: Controls Active Control 1 Intervention

20 patients with CMV infection will not be given Letermovir

Letermovir is already approved in United States, European Union for the following indications:

Approved in United States as Prevymis for:

• 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-])

Approved in European Union as Prevymis for:

• 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-])

Who Is Running the Clinical Trial?

Jean-Pierre Routy

Lead Sponsor

Trials

3

Recruited

130+