Islatravir + Ulonivirine for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks a simpler and potentially safer treatment for individuals with HIV-1 by testing a new combination of two drugs, islatravir (an experimental treatment) and ulonivirine, taken once a week. Researchers compare this new treatment to the usual daily medication to determine if it is equally effective and gentler on the body. Individuals diagnosed with HIV-1 who have not yet started any antiretroviral therapy might be suitable for this study. As a Phase 2 trial, the study measures the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for this trial?
The trial is for people who have not taken any antiretroviral therapy (ART) before, so if you are currently on ART, you would not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using islatravir and ulonivirine together to treat HIV-1 has produced mixed safety results. Some studies have examined weekly dosing of these medicines. One study stopped early in 2021 due to side effects linked to a build-up of islatravir inside cells. However, other research has focused on weekly doses and drug interactions to better understand their safety.
While evidence suggests the treatment can be tolerated, the early termination of some studies indicates potential concerns. Prospective trial participants should consider these findings and consult their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Islatravir and Ulonivirine for HIV because these drugs introduce a fresh approach to treatment. Unlike the standard daily regimens like Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), Islatravir and Ulonivirine are administered just once a week. This weekly dosing could significantly improve adherence and convenience for patients. Additionally, Islatravir has a unique mechanism of action that targets the HIV life cycle differently, potentially offering new hope for managing the virus more effectively.
What evidence suggests that this trial's treatments could be effective for HIV-1?
Research has shown that the combination of islatravir and ulonivirine, which participants in this trial may receive, effectively controls HIV-1. Studies have found that taking this treatment once a week keeps the virus at very low levels in the body. Early results also suggest that ulonivirine alone can help people who are new to treatment. This combination aims to simplify treatment by reducing the need for daily medication. Some patients experienced side effects, but the overall success in controlling the virus was promising.14678
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 adults with HIV-1 who haven't been treated before. They need to have a certain amount of the virus in their blood: at least 500 copies/mL, and if it's Phase 2 of the trial, no more than 100,000 copies/mL. Their immune system should also be relatively strong (CD4+ T-cell count ≥200 cells/mm³).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 2
Participants receive either ISL + ULO or BIC/FTC/TAF for 96 weeks
Treatment Phase 3
Participants receive either ISL/ULO and placebo to BIC/FTC/TAF or BIC/FTC/TAF and placebo to ISL/ULO for 96 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Islatravir
- Ulonivirine
Trial Overview
The study is testing a new ART that combines two medicines, Islatravir (ISL) and Ulonivirine (ULO), taken once weekly against standard ART which usually involves up to three daily meds. The goal is to see if this new regimen works as well as standard treatment.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks
Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks
Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks
BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks
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
A Clinical Study of Islatravir and Ulonivirine for People With ...
A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different ...
2.
eatg.org
eatg.org/hiv-news/investigational-once-weekly-art-combo-maintained-viral-suppression-in-hiv/Investigational once-weekly ART combo maintained viral ...
Drug-related adverse events occurred in 17.4% receiving islatravir/ulonivirine and 10% receiving BIC/FTC/TAF, with 2.5% receiving islatravir/ ...
Merck to Present New Data Highlighting Research ...
Data from two Phase 1 trials evaluating the safety and tolerability of weekly ulonivirine and drug interactions between islatravir and ...
Ulonivirine Patient Drug Record | NIH
Decreases in total lymphocyte and CD4 counts were seen in all islatravir plus ulonivirine study arms. Long-term follow-up showed that the declines in total ...
Ulonivirine Shows Promise for Weekly Oral HIV Treatment
Early studies showed that a single dose of ulonivirine monotherapy suppressed HIV in people new to treatment and its pharmacokinetics support ...
6.
eatg.org
eatg.org/hiv-news/once-weekly-oral-art-with-ulonivirine-plus-islatravir-24-week-phase-2-results/Once-weekly oral ART with ulonivirine plus islatravir
Once-weekly oral ART with ulonivirine plus islatravir: 24-week phase 2 results. Back to the "HIV and Co-Infections News" list. HIV Treatment.
Islatravir Health Professional Drug Record | NIH
Selected Study Results: Results presented at CROI 2023 and published in Lancet HIV (2024) indicated that DOR/ISL was as effective as baseline ART regimens ...
IAS 2025: Once-weekly oral ART with ulonivirine plus ...
However, use of ULO+ISL was stopped early in 2021 due to side effects linked to accumulation of intracellular islatravir triphosphates, which ...
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