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Study on Switching to Islatravir and MK-8507 for Adults with HIV-1 Who Are Virologically Suppressed on a Drug Combination

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of HIV-1 infection, a virus that attacks the immune system. The study is evaluating a new treatment approach involving two medications: Islatravir (ISL) and MK-8507. These medications are being tested for their safety and how well they are tolerated when taken once a week. The study also involves participants who are currently taking a daily combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide (BIC/FTC/TAF), which are medications commonly used to manage HIV-1.

The purpose of the study is to see if switching to the once-weekly regimen of ISL and MK-8507 is safe and well-tolerated. Participants in the study will be randomly assigned to receive either the new treatment or continue with their current daily medication. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will monitor participants over a period to gather information on any side effects and how the body responds to the new treatment.

Throughout the study, participants will have regular check-ups to ensure their health and safety. The study aims to provide valuable information on whether the new treatment can be a viable option for people living with HIV-1, potentially offering a more convenient dosing schedule. This research is important for advancing treatment options and improving the quality of life for individuals with HIV-1.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is confirmed to be HIV-1 positive with a plasma HIV-1 RNA level of less than 50 copies/mL.

    The participant has been virologically suppressed on a regimen of Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for at least six months.

    A screening is conducted to ensure a CD4+ T-cell count greater than 200 cells/mm³.

  2. Step 2

    Initial treatment phase

    Participants continue their current daily regimen of BIC/FTC/TAF tablets.

    This phase ensures stability before transitioning to the new treatment.

  3. Step 3

    Switch to new treatment

    Participants are randomized to switch to a once-weekly regimen of Islatravir (ISL) and MK-8507.

    The new treatment involves taking these medications orally in tablet form.

  4. Step 4

    Monitoring and assessment

    Regular monitoring is conducted to assess the safety and tolerability of the new treatment.

    Participants are evaluated for any adverse events and the percentage of participants discontinuing the study due to adverse events is recorded.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by September 30, 2024.

    Final assessments are conducted to evaluate the overall outcomes and safety data collected during the trial.

Who can join the trial?

5 criteria

  • The patient must be HIV-1 positive and have a very low amount of the virus in their blood, specifically less than 50 copies per milliliter, at the time of screening.
  • The patient should have been successfully controlling the virus with a specific medication combination (BIC/FTC/TAF) for at least 6 months.
  • The patient needs to have a certain level of CD4+ T-cells in their blood, which are important cells for the immune system. This level should be more than 200 cells per cubic millimeter, as checked by a central laboratory.
  • The patient must be at least 18 years old when they agree to participate in the study.
  • Female patients can join if they are not pregnant or breastfeeding. They must also meet one of these conditions: either they cannot become pregnant, or if they can, they must use a very effective birth control method or choose not to have heterosexual intercourse as a regular lifestyle choice.

Who cannot join the trial?

4 criteria

  • Individuals who do not have an HIV-1 infection cannot participate. HIV-1 is a type of virus that affects the immune system.
  • Participants must be within certain age ranges, typically adults, to be eligible.
  • Both male and female participants are eligible, but specific criteria may apply to each gender.
  • Individuals who are considered part of a vulnerable population are not eligible. This means people who might need special protection or care.
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Investigated drugs

  • Islatravir (ISL)

    is a medication being studied for its potential use in treating HIV-1. It is being evaluated for its safety and tolerability when taken once a week. The goal is to see if it can effectively maintain viral suppression in people who are already virologically suppressed on their current HIV treatment.

  • MK-8507

    is another medication included in the study, used in combination with Islatravir. It is also being tested for its safety and effectiveness when taken once a week. The combination aims to provide a simpler treatment regimen for people living with HIV-1, potentially improving adherence and quality of life.

  • Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

    is the current daily treatment for participants in the study. It is a combination of three medications used to keep the HIV virus suppressed. The study is comparing the new weekly regimen to this established daily treatment to see if the new approach is as safe and effective.

What is already known about the treatment

  • Islatravir

    Islatravir is administered orally and is currently being studied in clinical trials for its potential use in treating HIV-1 infection. It is in the investigational stage, with ongoing research to determine its safety and effectiveness. The main therapeutic indication for Islatravir is the treatment of HIV-1 in adults who are virologically suppressed. At the molecular level, Islatravir works by inhibiting the reverse transcriptase enzyme, which is crucial for the replication of the HIV virus. It is classified as a nucleoside reverse transcriptase translocation inhibitor (NRTTI).

  • MK-8507

    MK-8507 is also administered orally and is under investigation in clinical trials for its use in managing HIV-1 infection. Like Islatravir, it is in the research phase, with studies focusing on its safety and tolerability. The primary therapeutic use of MK-8507 is for treating HIV-1 in adults who have achieved viral suppression. MK-8507 functions by inhibiting the reverse transcriptase enzyme, preventing the virus from multiplying. It is classified as a non-nucleoside reverse transcriptase inhibitor (NNRTI).

Investigated diseases

HIV-1 Infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the immune system, specifically targeting CD4 cells. Over time, the virus reduces the number of these cells, weakening the body's ability to fight off infections and diseases. Initially, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without intervention, the infection can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of the disease varies among individuals, influenced by factors such as viral load and immune response. Regular monitoring and management are crucial to understanding the disease's impact on the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511041-19-00Protocol codeMK-8591-013Estimated enrolment161 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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