Islatravir + Ulonivirine for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of medications, islatravir and ulonivirine, for individuals with HIV-1 who have successfully managed their virus with their current treatment. The goal is to assess the safety and tolerability of these new medications compared to the standard treatment (BIC/FTC/TAF, a combination of antiretroviral drugs). This trial may suit someone who has maintained a stable HIV treatment for at least six months with no detectable virus in their blood. Participants will either continue their current treatment or switch to the new combination for the study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it requires that you have been on a specific HIV medication (BIC/FTC/TAF) for at least 6 months. It's best to discuss your current medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of islatravir and ulonivirine is generally well-tolerated. Safety results indicate that very few people stopped using the treatment due to side effects. In another study, 17.4% of participants taking islatravir and ulonivirine reported drug-related side effects, slightly higher than the 10% who experienced side effects with the standard treatment of BIC/FTC/TAF. However, only 2.5% of those on islatravir and ulonivirine discontinued due to these side effects. This suggests that while some side effects occur, they are usually not severe enough to cause discontinuation. Overall, the data so far shows that the treatment has a manageable safety profile.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Islatravir and Ulonivirine for HIV treatment because it offers a unique approach compared to standard treatments like BIC/FTC/TAF. Islatravir, a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI), works by blocking HIV replication at an early stage, which is different from most current options. Ulonivirine, a new non-nucleoside reverse transcriptase inhibitor (NNRTI), complements this by targeting the virus through another pathway. Additionally, these combinations being tested in once-weekly doses could simplify treatment regimens, potentially improving adherence and outcomes for individuals living with HIV.
What evidence suggests that this trial's treatments could be effective for HIV?
Research has shown that the combination of islatravir and ulonivirine effectively controls HIV-1. In this trial, participants will receive different doses of this combination, with each group testing a specific dose level. Studies have shown promising results in maintaining viral control, with data revealing that taking islatravir and ulonivirine once a week kept the virus suppressed for 24 weeks. This is encouraging for those who prefer less frequent dosing. Some drug-related side effects were reported, but they were generally manageable. Overall, these findings suggest that this combination could be a strong option for managing HIV-1.12346
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
Adults over 18 with HIV-1 who've been virologically suppressed for at least 6 months using BIC/FTC/TAF can join. They must have a CD4+ T-cell count >200 cells/mm^3 and an HIV-1 RNA <50 copies/mL. Women can't be pregnant, breastfeeding, or planning to conceive; they must use effective contraception or practice abstinence.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ISL + ulonivirine or placebo to ISL + ulonivirine, and BIC/FTC/TAF or placebo to BIC/FTC/TAF
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants who received ISL + ulonivirine will be followed for long-term safety and effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- BIC/FTC/TAF
- Islatravir
- Ulonivirine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
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