Ulonivirine for Heart Rhythm Evaluation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new HIV-1 treatment called ulonivirine to determine its effect on heart rhythm. Ulonivirine is designed as a safe and easy-to-take medicine for HIV-1, the most common type of HIV virus. Researchers aim to find out if ulonivirine changes the QT interval, a measure of heart rhythm shown on an ECG (a test that measures heart activity). They also seek to understand how the body processes ulonivirine over time. Healthy individuals with a body mass index (BMI) between 18 and 32, who have no history of major diseases, may be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how ulonivirine works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that when ulonivirine is combined with another drug, islatravir, it produces side effects similar to those of Biktarvy, a well-known HIV medication. This suggests that ulonivirine is generally well-tolerated. The study is currently in its early stage, focusing primarily on safety. This phase ensures the treatment does not cause serious side effects. While this does not guarantee complete safety, these early stages are crucial for understanding the body's reaction to the drug.12345
Why do researchers think this study treatment might be promising for HIV-1?
Ulonivirine is unique because it offers a new approach to managing heart rhythm issues. Unlike current treatments, which often include beta-blockers or antiarrhythmic drugs targeting ion channels, ulonivirine may work through a novel mechanism that directly influences the signaling pathways involved in heart rhythm regulation. Researchers are excited about ulonivirine because it has the potential to provide a more precise and effective treatment option, with potentially fewer side effects, for individuals with heart rhythm disorders.
What evidence suggests that ulonivirine might be an effective treatment for HIV-1?
Research has shown that ulonivirine is under study as a treatment for HIV-1, a virus that weakens the immune system. This new medicine is designed for less frequent dosing while remaining safe and well-tolerated. The current trial focuses on ulonivirine's effects on heart rhythm, particularly the QT interval, which measures heart rhythm stability. Participants will receive either ulonivirine or moxifloxacin, each with a placebo counterpart, to evaluate these effects. Although detailed human data on ulonivirine's effectiveness in treating HIV-1 is limited, it is being developed to meet the need for effective treatments with less frequent dosing. Early findings suggest it could be promising due to its potential benefits in dosing convenience and safety.36789
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for healthy adults with a BMI between 18 and 32 kg/m2. It's designed to test Ulonivirine, a new medication aimed at treating the most common type of HIV. Participants should be in good health before joining.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ulonivirine or placebo to evaluate the effect on QT interval and plasma concentration
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ulonivirine
Trial Overview
The study tests if Ulonivirine affects heart rhythm, specifically not increasing the QT interval dangerously. It also examines how the drug behaves in the body over time compared to placebos and Moxifloxacin, an antibiotic known to affect heart rhythm.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1.
Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
Effectiveness of nirmatrelvir/ritonavir and molnupiravir ... - PMC
Wang et al. showed that nirmatrelvir/ritonavir significantly reduced the risks of cerebrovascular complications, arrhythmia, ischemic heart ...
HIV Selected Articles
Recent articles on HIV. Check out articles on HIV related Bone Issues and HIV and Aging. null.gif ...
Prevalence, Outcomes, and Management of Ventricular ...
We review the current data on epidemiology, the clinical significance, the pathophysiologic mechanisms, and the treatment of VAs in the setting of COVID-19.
Worldwide Survey of COVID-19–Associated Arrhythmias
Cardiac comorbidities were common in patients with arrhythmia: 69% had hypertension, 42% diabetes, 30% had heart failure, and 24% had coronary artery disease. ...
A pooled analysis of 9 clinical trials
After a median follow-up of 631 days (interquartile range, 385–865 days), there were 243 WHFHs in 173 patients (9.4%) and 122 deaths (6.6%), ...
Ulonivirine Patient Drug Record | NIH
Available safety data showed that islatravir plus ulonivirine had a comparable side effect profile to that of Biktarvy.
Abstract Supplement Abstracts from IAS 2025, the 13th ... - PMC
A double‐blind, active‐controlled, phase 2b study to evaluate the efficacy and safety of ulonivirine in combination with islatravir in virologically suppressed ...
8.
iasociety.org
iasociety.org/sites/default/files/IAS2025/abstract-book/IAS-2025_Abstracts_Medium.pdfIAS 2025 abstract book
Over 5,250 abstracts were submitted to IAS 2025, the 13th. IAS Conference on HIV Science. The Organizing Commit- tee (OC) is very grateful for all the ...
Ulonivirine Health Professional Drug Record | NIH
Available safety data showed that islatravir plus ulonivirine had a comparable AE profile to that of Biktarvy.
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