← Back to Search

Viral DNA Terminase Inhibitor

Letermovir for HIV (Letermovir Trial)

N/A
Recruiting
Research Sponsored by Jean-Pierre Routy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sexually active men with a female partner of childbearing potential must agree to methods of birth control
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights

Letermovir Trial Summary

This trial is testing whether or not the drug letermovir has an effect on gut damage in HIV patients. 60 HIV positive patients will be observed, 40 of which will take letermovir in addition to their regular HIV medication, and 20 will only receive regular HIV medication. There will be follow up visits at 2, 4, and 14 weeks to assess the effects of letermovir. There is also an optional sub-study that will involve colonoscopies and colon biopsies.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Letermovir may cause side effects such as headaches, tiredness, nausea, diarrhea, coughing and potential allergic reactions. Since it's taken orally alongside other medications for HIV treatment, interactions that affect organ function could also occur.

Letermovir Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man and will use birth control if my partner can have children.

Letermovir Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gut Inflammation
Secondary outcome measures
Anti-CMV immune response
CMV DNA detection in gut
Gut permeability
+1 more

Side effects data

From 2016 Phase 3 trial • 570 Patients • NCT02137772
39%
Graft versus host disease
29%
Diarrhoea
28%
Nausea
24%
Rash
23%
Pyrexia
21%
Vomiting
17%
Cough
16%
Oedema peripheral
16%
Headache
15%
Cytomegalovirus infection
15%
Fatigue
13%
Abdominal pain
12%
Mucosal inflammation
12%
Decreased appetite
10%
Blood creatinine increased
10%
Dyspnoea
9%
Hypertension
9%
Acute kidney injury
9%
Oropharyngeal pain
9%
Insomnia
9%
Erythema
8%
Hyperkalaemia
8%
Febrile neutropenia
8%
Asthenia
8%
Hyperglycaemia
8%
Constipation
8%
Arthralgia
8%
Dizziness
8%
Tremor
8%
Dry skin
8%
Pruritus
7%
Alanine aminotransferase increased
7%
Epistaxis
7%
Thrombocytopenia
6%
Dyspepsia
6%
Stomatitis
6%
Bacteraemia
6%
Aspartate aminotransferase increased
6%
Acute myeloid leukaemia recurrent
6%
Anaemia
6%
Dry eye
6%
Abdominal pain upper
6%
Dry mouth
6%
Hypokalaemia
6%
Hypomagnesaemia
6%
Hyponatraemia
6%
Back pain
6%
Myalgia
6%
Anxiety
5%
Nasopharyngitis
5%
Dysuria
5%
Neutropenia
5%
Chest pain
5%
Pain in extremity
5%
Dysgeusia
4%
Hypotension
4%
Pneumonia
4%
Rhinorrhoea
3%
Viraemia
3%
Muscle spasms
2%
Gastrooesophageal reflux disease
2%
Acute lymphocytic leukaemia recurrent
2%
Respiratory failure
2%
Sepsis
2%
Acute myeloid leukaemia
1%
Hepatic function abnormal
1%
Pneumonia bacterial
1%
Staphylococcal bacteraemia
1%
Viral haemorrhagic cystitis
1%
Squamous cell carcinoma
1%
Multiple organ dysfunction syndrome
1%
Gastroenteritis
1%
Gastrointestinal haemorrhage
1%
Urinary tract infection
1%
Sinusitis
1%
Pneumothorax
1%
Venoocclusive liver disease
1%
Plasma cell myeloma recurrent
1%
Herpes zoster
1%
Pleural effusion
1%
Pancytopenia
1%
Bronchopulmonary aspergillosis
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Transplant failure
1%
Myelodysplastic syndrome
1%
Epstein-Barr virus infection
1%
Gastroenteritis viral
1%
Rhinovirus infection
1%
Septic shock
1%
Neurotoxicity
1%
Acute lymphocytic leukaemia
1%
Mantle cell lymphoma
1%
Sciatica
1%
Syncope
1%
Cystitis haemorrhagic
1%
Acute respiratory distress syndrome
1%
Venoocclusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Letermovir

Letermovir Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LetermovirExperimental Treatment1 Intervention
40 patients with CMV infection will be treated with Letermovir
Group II: ControlsActive Control1 Intervention
20 patients with CMV infection will not be given Letermovir
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir
2019
Completed Phase 3
~1410

Find a Location

Who is running the clinical trial?

Jean-Pierre RoutyLead Sponsor
2 Previous Clinical Trials
70 Total Patients Enrolled
Carolina A Berini, BSc, PhDStudy DirectorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Media Library

Letermovir (Viral DNA Terminase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05362916 — N/A
People Living With HIV Research Study Groups: Letermovir, Controls
People Living With HIV Clinical Trial 2023: Letermovir Highlights & Side Effects. Trial Name: NCT05362916 — N/A
Letermovir (Viral DNA Terminase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05362916 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible for participation in this research project?

"This trial seeks to recruit 60 people living with HIV, aged between 18 and 99. To meet the criteria for participation, applicants must prove their infection through a Western Blot, EIA or viral load assay; be on ART for at least three years using the same prescription; have CMV seropositivity as indicated by clinical lab test results; possess CD4 count of over 400 cells/µL of blood in addition to being able to communicate effectively in French or English. Further eligibility considerations include having passed a negative serum pregnancy test (for women of childbearing potential), demonstrating an undetectable viral load <50 copies/ml"

Answered by AI

Can individuals still join this medical research endeavor?

"Currently, this medical trial is open for enrollment. The first posting was made on September 26th 2022 and the advertisement has been updated as recently October 31st of the same year."

Answered by AI

What is the aggregate number of participants in this experiment?

"Affirmative. The information available on clinicaltrials.gov verifies that this trial is presently accepting participants. It was initially posted on September 26th 2022 and last revised at the end of October in the same year, with an aim to recruit 60 patients from 1 medical centre."

Answered by AI

Does this trial accept elderly participants aged over 75?

"This medical experiment is seeking individuals aged 18 to 99 who are willing to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Letermovir in ART-treated HIV-infected Persons
Jean-Pierre Routy 2022. "Letermovir in ART-treated HIV-infected Persons". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05362916.
~23 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top