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Letermovir for Cytomegalovirus

University of Rochester Adult HIV Therapeutic Strategies Network CRS, Rochester, NY
Cytomegalovirus+2 More ConditionsLetermovir - Drug
Eligibility
18+
All Sexes
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Study Summary

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

Eligible Conditions
  • Cytomegalovirus
  • Human Immunodeficiency Virus (HIV) Infection

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Artesunate suppositories
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Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
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Letermovir

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Baseline and weeks 46 and 48.

Baseline and week 46
Change from baseline in sCD163 at week 46
Baseline and week 48
Change from baseline in sCD163 at week 48
Baseline and week 52
Change from baseline in sCD163 at week 52
Change from baseline in sTNFRII at week 52
Baseline and week 60
Change from baseline in sCD163 at week 60
Change from baseline in sTNFRII at week 60
Incidence of Grade ≥3 AEs
Baseline and week 8
Change from baseline in sCD163 at week 8
Change from baseline in sTNFRII at week 8
Week 46
Change from the average at baseline (entry and treatment initiation visits) in sTNFRII at week 48
Measured through week 60
Mucosal CMV DNA levels
Plasma CMV DNA levels

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Artesunate suppositories
1
Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
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Letermovir

Side Effects for

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

3 Treatment Groups

Arm A: letermovir
1 of 3
Arm A: Letermovir
1 of 3
Arm B: placebo
1 of 3

Experimental Treatment

Non-Treatment Group

180 Total Participants · 3 Treatment Groups

Primary Treatment: Letermovir · Has Placebo Group · Phase 2

Arm A: letermovirExperimental Group · 2 Interventions: Letermovir, Combination ART · Intervention Types: Drug, Drug
Arm A: LetermovirExperimental Group · 3 Interventions: Combination ART, Letermovir 240 MG Oral Tablet, Letermovir 480 MG Oral Tablet · Intervention Types: Drug, Drug, Drug
Arm B: placeboPlaceboComparator Group · 2 Interventions: Placebo, Combination ART · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and weeks 46 and 48.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,183 Previous Clinical Trials
4,980,718 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,733 Previous Clinical Trials
4,973,244 Total Patients Enrolled
Sara Gianella, MDStudy ChairUniversity of California, San Diego, AntiViral Research Center CRS
1 Previous Clinical Trials
90 Total Patients Enrolled
Peter Hunt, MDStudy ChairUniversity of California, San Francisco, HIV/AIDS CRS

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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