What side effects are associated with this type of intervention?

Common treatments for People Living With HIV (PLWH) include antiretroviral therapies (ART) such as emtricitabine, which is similar to lamivudine. These treatments often have side effects including headache, pain, fatigue, fever, abdominal pain, nausea, vomiting, and diarrhea. Other antiviral treatments, like those for CMV, may include drugs like Letermovir, which generally have a good safety profile but can cause gastrointestinal symptoms and potential drug interactions. It is important for patients to discuss these side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved various antiretroviral drugs for the treatment of People Living With HIV (PLWH). These include protease inhibitors like darunavir and ritonavir, integrase inhibitors such as raltegravir, and entry inhibitors like maraviroc. While Letermovir specifically targets the CMV DNA terminase complex and is being studied for its effects on gut damage in ART-treated HIV-infected individuals, the primary focus of FDA-approved HIV treatments remains on controlling the HIV virus itself through a combination of antiretroviral therapies.

What other types of research exist?

Promising novel alternatives to Letermovir for PLWH in 2024 include maribavir, which inhibits CMV UL97 protein kinase, and brincidofovir, a lipid conjugate of cidofovir with improved safety and efficacy profiles. Both agents have shown effectiveness in treating CMV infections and may offer additional options for managing CMV in PLWH.

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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

Must not have

Severe systemic diseases (e.g. uncontrolled hypertension, chronic renal failure), or active uncontrolled infections including Coronavirus disease 19 (COVID-19) (as tested by PCR)

Current AIDS-related event or serious health condition including systemic infections in the last 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man and will use birth control if my partner can have children.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have moderate liver and kidney issues.

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I am not taking any medication that interacts with letermovir.

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I do not have an active Hepatitis B or C infection.

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I am not allergic to letermovir or any ingredient in PREVYMIS®.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gut Inflammation

Secondary study objectives

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

Hypertension

Acute kidney injury

Oropharyngeal pain

Insomnia

Erythema

Febrile neutropenia

Hyperkalaemia

Asthenia

Hyperglycaemia

Constipation

Arthralgia

Dizziness

Tremor

Dry skin

Pruritus

Alanine aminotransferase increased

Epistaxis

Thrombocytopenia

Dyspepsia

Stomatitis

Bacteraemia

Aspartate aminotransferase increased

Acute myeloid leukaemia recurrent

Anaemia

Dry eye

Abdominal pain upper

Dry mouth

Hypokalaemia

Hypomagnesaemia

Hyponatraemia

Back pain

Myalgia

Anxiety

Nasopharyngitis

Dysuria

Neutropenia

Chest pain

Pain in extremity

Dysgeusia

Hypotension

Pneumonia

Rhinorrhoea

Viraemia

Muscle spasms

Gastrooesophageal reflux disease

Acute lymphocytic leukaemia recurrent

Respiratory failure

Sepsis

Acute myeloid leukaemia

Hepatic function abnormal

Sinusitis

Gastrointestinal haemorrhage

Viral haemorrhagic cystitis

Staphylococcal bacteraemia

Urinary tract infection

Pneumothorax

Venoocclusive liver disease

Multiple organ dysfunction syndrome

Pneumonia bacterial

Plasma cell myeloma recurrent

Squamous cell carcinoma

Gastroenteritis

Herpes zoster

Pleural effusion

Pancytopenia

Bronchopulmonary aspergillosis

Cellulitis

Clostridium difficile colitis

Transplant failure

Myelodysplastic syndrome

Epstein-Barr virus infection

Gastroenteritis viral

Rhinovirus infection

Septic shock

Neurotoxicity

Acute lymphocytic leukaemia

Mantle cell lymphoma

Sciatica

Syncope

Cystitis haemorrhagic

Acute respiratory distress syndrome

Venoocclusive disease

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Letermovir

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1530

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antiretroviral therapy (ART) for People Living With HIV (PLWH) includes drugs that target different stages of the HIV life cycle. Reverse transcriptase inhibitors prevent the conversion of viral RNA into DNA, protease inhibitors block the protease enzyme needed for viral replication, integrase inhibitors prevent the integration of viral DNA into the host genome, and entry inhibitors block the virus from entering host cells. These mechanisms are crucial as they collectively suppress viral load, improve immune function, and reduce the risk of opportunistic infections. Similar to Letermovir, which inhibits the CMV DNA terminase complex, these treatments aim to disrupt viral replication, thereby enhancing the quality of life and longevity for PLWH.

Artemisone demonstrates synergistic antiviral activity in combination with approved and experimental drugs active against human cytomegalovirus.Approach to drug-resistant cytomegalovirus in transplant recipients.Improving HIV infection management using antiretroviral plasma drug levels monitoring: a clinician's point of view.