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Antiviral

Letermovir for HIV-Related Inflammation (ELICIT Trial)

Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 46 and 48.
Awards & highlights

ELICIT Trial Summary

This trial will compare the anti-inflammatory effectiveness of letermovir to no treatment in adults with HIV and asymptomatic CMV.

Who is the study for?
Adults over 40 with HIV-1, on stable ART for at least 48 weeks, and have suppressed viral loads. They must also have a positive CMV IgG serology indicating past or current infection but no active disease. Participants need normal organ function tests and agree to use contraception if of reproductive potential.Check my eligibility
What is being tested?
The study is testing the anti-inflammatory effects of Letermovir in adults with HIV-1 and asymptomatic CMV who are already on suppressive antiretroviral therapy (ART). It's an open-label trial where participants will either receive Letermovir daily or no treatment for CMV for 48 weeks.See study design
What are the potential side effects?
Letermovir may cause side effects like headaches, tiredness, nausea, diarrhea, coughing, and potentially affect liver enzymes. Some people might experience swelling in their limbs or changes in their heart rhythm.

ELICIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 46 and 48.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 46 and 48. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from the average at baseline (entry and treatment initiation visits) in sTNFRII at week 48
Secondary outcome measures
Change from baseline in sCD163 at week 46
Change from baseline in sCD163 at week 48
Change from baseline in sCD163 at week 52
+8 more

ELICIT Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: No anti-CMV treatmentExperimental Treatment1 Intervention
Group II: Arm A: LetermovirExperimental Treatment3 Interventions
Letermovir 480 mg will be administered by one of the following strategies: Letermovir 240 mg tablets administered orally as two tablets once daily with or without food. Letermovir 480 mg tablets administered orally as one tablet once daily with or without food. Participants will be able to switch administration strategy during treatment duration based on availability of study supply.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir 240 MG Oral Tablet
2022
Completed Phase 2
~50
Combination ART
2022
Completed Phase 2
~50
Letermovir 480 MG Oral Tablet
2022
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,425 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,570 Total Patients Enrolled
Sara Gianella, MDStudy ChairUniversity of California, San Diego, AntiViral Research Center CRS
1 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

Letermovir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT04840199 — Phase 2
Human Immunodeficiency Virus Infection Research Study Groups: Arm A: Letermovir, Arm B: No anti-CMV treatment
Human Immunodeficiency Virus Infection Clinical Trial 2023: Letermovir Highlights & Side Effects. Trial Name: NCT04840199 — Phase 2
Letermovir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04840199 — Phase 2

Frequently Asked Questions

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

How many people are being signed up for this clinical trial?

"One-hundred-and-eighty participants who meet the clinical study's inclusion criteria are required. The sponsor, Merck Sharp & Dohme LLC, will be managing the trial from various locations - such as Massachusetts General Hospital CRS (MGH CRS) in Boston, Massachusetts and Northwestern University CRS in Chicago, Illinois."

Answered by AI

Is this the initial study of its kind?

"There are 7 active clinical trials for Letermovir in 11 countries and 34 cities. The first trial was sponsored by Merck Sharp & Dohme LLC in 2019. That initial study had 86 participants and completed Phase 2 drug approval. To date, 18296 trials have been conducted since the original one in 2019."

Answered by AI

Are there any open vacancies for this research project?

"That is correct. The page on clinicaltrials.gov dedicated to this study says that it is still open for patient recruitment. This trial was first posted on November 2nd, 2020 and updated less than a week ago on the 10th of November. In total, they are hoping to have 180 patients from 19 different locations sign up."

Answered by AI

Are there other Letermovir research projects that have been conducted in the past?

"Right now, there are seven ongoing clinical trials researching Letermovir. None of the active studies are in Phase 3. However, even though most of the Letermovir trials are based in Columbus, Ohio, 66 different locations are running these tests."

Answered by AI

Is Letermovir known to cause any life-threatening side effects?

"While there is not yet data supporting Letermovir's efficacy, phase 2 trials suggest that it is safe."

Answered by AI

How many different research facilities are overseeing this project?

"So far, this trial has recruited 19 patients from locations including the Massachusetts General Hospital CRS (MGH CRS) in Boston, Northwestern University CRS in Chicago, and Penn Therapeutics, CRS in Philadelphia."

Answered by AI

Who else is applying?

What site did they apply to?
Alabama CRS
University of Colorado Hospital CRS
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.
2022. "A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04840199.
~18 spots leftby Apr 2025
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