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Study Comparing Weekly Islatravir/Lenacapavir Regimen to Standard Care in HIV Patients with Controlled Viral Load

Verified siteRegistered drugNo placebo
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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 body's immune system. The study will compare a new treatment option, an oral weekly regimen of Islatravir and Lenacapavir, with the current standard of care for people who have their virus under control, known as being virologically suppressed. The purpose of the study is to evaluate how effective the new treatment is compared to the standard treatment over a period of 48 weeks.

Participants in the study will be randomly assigned to either continue their current standard treatment or switch to the new weekly oral regimen. The study will monitor the participants' health and the level of the virus in their blood at various points, including at 48 weeks and 96 weeks. The study will also look at changes in the participants' immune cell counts, specifically CD4 T-cells, which are important for fighting infections.

The study will involve taking medication by mouth, and participants will be closely monitored for any side effects or changes in their health. The trial aims to provide more information on whether the new treatment can be a viable option for people living with HIV-1 who are already managing their condition well with existing treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of trial participation

    Upon joining the study, participants will be confirmed to have HIV-1 RNA levels below 50 copies/mL, ensuring they are virologically suppressed.

    Participants must be receiving standard care treatment for at least six months prior to the start of the trial.

  2. Step 2

    Randomization and treatment assignment

    Participants will be randomly assigned to one of two groups: one group will switch to a weekly oral regimen of islatravir/lenacapavir, while the other group will continue their current standard of care treatment.

  3. Step 3

    Treatment administration

    For those in the islatravir/lenacapavir group, the medication will be taken orally once a week.

    Participants continuing with standard care will maintain their current regimen as prescribed.

  4. Step 4

    Monitoring and assessments

    Regular monitoring will occur to assess HIV-1 RNA levels at specified intervals, including at Week 48 and Week 96.

    Additional assessments will include changes in CD4 T-cell counts and monitoring for any adverse effects from the treatment.

  5. Step 5

    Evaluation of primary and secondary endpoints

    The primary endpoint is the proportion of participants with HIV-1 RNA levels of 50 copies/mL or more at Week 48.

    Secondary endpoints include the proportion of participants with HIV-1 RNA levels below 50 copies/mL at Weeks 48 and 96, changes in CD4 T-cell counts, and the percentage of participants discontinuing the islatravir/lenacapavir regimen due to adverse events.

  6. Step 6

    Completion of trial participation

    Participants will complete the trial after the final assessments at Week 96, with the option to continue their standard care treatment as needed.

Who can join the trial?

6 criteria

  • Participants must be **18 years of age or older** and able to understand and give written consent to join the study.
  • Participants must have **HIV-1 RNA levels** (a measure of the virus in the blood) of less than 50 copies/mL for at least 6 months before the study starts. This means the virus is well-controlled.
  • Participants must have **HIV-1 RNA levels** of less than 50 copies/mL at the time of screening for the study.
  • Participants must be receiving a **standard treatment** for HIV, which usually includes 2 or 3 antiretroviral drugs (ARVs), for at least 6 months before the study starts. They must be willing to continue this treatment until the study begins. Some participants may need to continue their treatment for at least 96 weeks.
  • Individuals who were assigned female at birth and can become pregnant must agree to use specific methods of **contraception** if they have heterosexual intercourse.
  • Other specific criteria defined in the study protocol may also apply.

Who cannot join the trial?

5 criteria

  • Patients who are not currently taking medication for **HIV-1 infection** cannot participate. **HIV-1 infection** is a type of virus that affects the immune system.
  • Patients who are not **virologically suppressed** cannot participate. **Virologically suppressed** means that the virus is under control and not actively multiplying in the body.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are not willing to switch to the new treatment method cannot participate. The study involves changing to a new type of medication.
  • Patients who are not able to follow the study procedures cannot participate. This means they must be able to attend appointments and take medication as directed.
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Investigated drugs

  • Islatravir

    is an investigational medication being studied for its potential use in treating HIV-1. It is designed to be taken orally once a week and works by interfering with the virus's ability to replicate, helping to control the infection in people who are already virologically suppressed.

  • Lenacapavir

    is another investigational medication included in the study. Like Islatravir, it is intended for oral use once a week. Lenacapavir targets a different part of the HIV-1 virus, aiming to prevent it from multiplying and spreading in the body, thereby maintaining viral suppression in individuals with HIV-1.

What is already known about the treatment

  • Islatravir

    Islatravir is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating HIV-1 infection. It is in the investigational stage, with ongoing research to determine its efficacy and safety. The main therapeutic indication for Islatravir is the treatment of HIV-1 in individuals 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).

  • Lenacapavir

    Lenacapavir is also administered orally in tablet form and is being evaluated in clinical trials for its potential use in treating HIV-1 infection. It is still under investigation, with studies focusing on its ability to maintain viral suppression in patients. The primary therapeutic use of Lenacapavir is for individuals with HIV-1 who are already virologically suppressed. Lenacapavir acts by inhibiting the HIV capsid, which is essential for the virus's ability to replicate and assemble. It is classified as a capsid inhibitor.

Investigated diseases

HIV-1 Infection – Human Immunodeficiency Virus type 1 (HIV-1) is a virus that attacks the immune system, specifically targeting CD4 T-cells, which are crucial for immune defense. Over time, HIV-1 can lead to a significant decrease in CD4 T-cell count, weakening the immune system and making the body more susceptible to infections and certain diseases. The virus is primarily transmitted through contact with infected bodily fluids, such as blood, semen, vaginal fluids, and breast milk. In the early stages, individuals may experience flu-like symptoms, but as the infection progresses, it can remain asymptomatic for years. Without intervention, the continuous decline in immune function can lead to Acquired Immunodeficiency Syndrome (AIDS), characterized by severe immune system damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514047-28-00Protocol codeGS-US-563-5926Estimated enrolment634 patientsSponsorGilead Sciences Inc.

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