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Study of Weekly Oral GS-1720 and GS-4182 for People with HIV-1 Who Are Virologically Suppressed

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 immune system. The study will compare two different treatment approaches for people whose virus is currently under control. One group will switch to a new weekly oral treatment combining two experimental drugs, GS-1720 and GS-4182. The other group will continue their current daily treatment with Biktarvy, a medication that combines three active ingredients: emtricitabine, tenofovir alafenamide, and bictegravir.

The purpose of the study is to evaluate the effectiveness and safety of the new weekly treatment compared to the existing daily treatment. Participants will be randomly assigned to one of the two groups. The study will be conducted in two phases. In the first phase, the effectiveness of the weekly treatment will be assessed over 24 weeks. In the second phase, the study will continue for up to 48 weeks to further evaluate the long-term effects of the treatments.

Throughout the study, participants will have regular check-ups to monitor their health and the levels of the virus in their blood. The study aims to provide valuable information on whether the new weekly treatment can be a safe and effective alternative to the current daily regimen for people living with HIV-1.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the HIV-1 RNA level is less than 50 copies/mL for at least 24 weeks before and at the time of screening.

    Participants must have been receiving Biktarvy for at least 24 weeks prior to screening.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one group continues with the current treatment of Biktarvy, while the other group switches to a new regimen of oral weekly GS-1720 in combination with GS-4182.

  3. Step 3

    Treatment phase 2

    For those switching to the new regimen, GS-1720 and GS-4182 are taken orally once a week. The efficacy of this regimen is evaluated at Week 24.

    Participants continuing with Biktarvy maintain their current daily dosage of 50 mg/200 mg/25 mg film-coated tablets.

  4. Step 4

    Evaluation at week 24

    At Week 24, the primary endpoint is assessed. This involves determining the proportion of participants with HIV-1 RNA levels of 50 copies/mL or more.

    Secondary endpoints include the proportion of participants with HIV-1 RNA levels below 50 copies/mL and changes in CD4+ T-cell count.

  5. Step 5

    Treatment phase 3

    Participants who continue in the study proceed to Phase 3, where the new regimen of GS-1720 and GS-4182 is evaluated at Week 48.

    The same evaluation criteria as in Phase 2 are applied, with additional assessments at Week 96.

  6. Step 6

    Evaluation at week 48 and 96

    At Week 48, the primary endpoint is again assessed, focusing on the proportion of participants with HIV-1 RNA levels of 50 copies/mL or more.

    Secondary endpoints include the proportion of participants with HIV-1 RNA levels below 50 copies/mL, changes in CD4+ T-cell count, and the occurrence of any treatment-emergent adverse events.

Who can join the trial?

4 criteria

  • Participants must be **18 years of age or older** and able to understand and give written informed consent.
  • Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of **contraception**. This means using methods to prevent pregnancy as outlined in the study guidelines.
  • Participants must have **documented plasma HIV-1 RNA** levels of less than 50 copies/mL for at least 24 weeks before and at the time of screening. This means their HIV levels in the blood are very low and have been stable for at least 24 weeks.
  • Participants must have been receiving **BVY** (Biktarvy®) for at least 24 weeks prior to screening. BVY is a medication used to treat HIV.

Who cannot join the trial?

5 criteria

  • Individuals who are not virologically suppressed. This means their HIV-1 virus levels are not well controlled by their current treatment.
  • Individuals who are not taking the specific medication called Biktarvy®, which is a combination of three drugs used to treat HIV-1 infection.
  • Individuals who are not able to switch to the new treatment being tested in the study.
  • Individuals who are not within the specified age range for the study.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • GS-1720

    is an experimental medication being tested for its effectiveness in treating people with HIV-1. It is taken orally once a week and is being studied to see if it can maintain viral suppression in patients who are already virologically suppressed.

  • GS-4182

    is another experimental medication used in combination with GS-1720. It is also taken orally once a week. The combination of GS-1720 and GS-4182 is being evaluated to determine if it can effectively maintain viral suppression in people with HIV-1.

  • Biktarvy

    is a medication that combines three active ingredients: bictegravir, emtricitabine, and tenofovir alafenamide. It is used to treat HIV-1 and is taken daily. In this study, Biktarvy is used as a comparison to evaluate the effectiveness of the new weekly regimen of GS-1720 and GS-4182.

What is already known about the treatment

  • GS-1720

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating HIV-1 infection. It is in the experimental phase and not yet widely recognized in medical literature. The main therapeutic indication is for individuals with HIV-1 who are virologically suppressed. GS-1720 works by interfering with the virus's ability to replicate, helping to maintain low levels of the virus in the body. It is classified as an antiretroviral agent.

  • GS-4182

    This medication is also taken orally and is being evaluated in combination with GS-1720 for the treatment of HIV-1 infection. It is still under investigation and not yet established in medical practice. The primary use is for people with HIV-1 who have achieved viral suppression. GS-4182 functions by targeting specific viral proteins, preventing the virus from multiplying. It belongs to the class of antiretroviral drugs.

  • Biktarvy

    This medication is an oral tablet that is already approved and used in the treatment of HIV-1 infection. It is well-documented in medical literature and is indicated for individuals who are virologically suppressed. Biktarvy combines three active ingredients that work together to block the virus's replication process. It is classified as a combination antiretroviral therapy.

Investigated diseases

HIV-1 Infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the body's immune system, specifically the CD4 cells (T cells). Over time, HIV-1 can destroy so many of these cells that the body can't fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. Initially, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without intervention, HIV-1 can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of the disease can vary greatly among individuals, influenced by factors such as viral load and the individual's overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-511054-50-00Protocol codeGS-US-695-6509Estimated enrolment82 patientsSponsorGilead Sciences Inc.

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