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Safety and efficacy of GS-3242 drug combination compared with standard drug combination in treatment‑naive adults with HIV‑1

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

The study focuses on people newly diagnosed with HIV-1. It compares a new injectable regimen that includes GS-3242 together with Lenacapavir to the standard once‑daily pill known as Biktarvy.

The purpose is to determine whether the injectable combination can control the virus as effectively as the daily pill in individuals who have not received treatment before. Participants will be assigned to receive either the injections at scheduled visits or the oral tablet taken each day, and they will return for regular check‑ups over a period of about one year.

During the study, blood tests will be used to measure the amount of virus in the blood and to count immune cells that help fight infection, while any side effects or health changes will be recorded to assess safety.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Assignment to Treatment Group

    After enrollment, you will be randomly assigned to either the test regimen or the comparator regimen. The assignment determines which medication(s) you will receive for the duration of the study.

  2. Step 2

    Start of Comparator Regimen (Biktarvy)

    If you are assigned to the comparator group, you will begin taking Biktarvy tablets. Each tablet contains 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide. The tablet is taken by mouth once daily for the entire study period.

  3. Step 3

    Start of Test Regimen (GS-3242 and Lenacapavir)

    If you are assigned to the test group, you will receive two medicines:

    GS-3242 – a 450 mg oral suspension intended for injection, administered according to the study schedule.

    Lenacapavir – a 600 mg film‑coated tablet taken by mouth as directed by the study team.

  4. Step 4

    First Follow‑Up Visit (Week 12)

    At week 12 you will attend a clinic visit. Blood will be drawn to measure HIV-1 RNA (the amount of virus in your blood) and the CD4 cell count (a type of immune cell). You will also be asked about any side effects you have experienced.

  5. Step 5

    Second Follow‑Up Visit (Week 26)

    At week 26 you will have another clinic visit. The same laboratory tests for HIV-1 RNA and CD4 cell count will be performed, and safety information will be collected. This visit is the primary efficacy assessment for participants in Phase 2 Part B.

  6. Step 6

    Third Follow‑Up Visit (Week 35)

    At week 35 you will return for a clinic visit. Blood samples will again be taken to evaluate HIV-1 RNA suppression and CD4 cell count. This visit serves as the primary efficacy assessment for participants in Phase 2 Part A.

  7. Step 7

    Final Study Visit (Week 52)

    At week 52 you will complete the primary study assessments. Blood will be drawn to determine the proportion of participants with HIV-1 RNA below 50 copies/mL and to record the CD4 cell count. Safety monitoring, including reporting of any adverse events, will also be performed. This visit marks the primary endpoint for Phase 2 and Phase 3.

  8. Step 8

    Extended Follow‑Up (Week 104)

    If you remain in the study for Phase 3, an additional visit at week 104 will be scheduled. The same laboratory tests for HIV-1 RNA and CD4 cell count will be performed, and ongoing safety will be evaluated.

Who can join the trial?

3 criteria

  • HIV‑1 RNA ≥ 500 copies/mL at screening – you must have a measurable amount of the virus in your blood (called viral load) that is at least 500 copies per milliliter when tested.
  • ARV treatment‑naive – you must not have taken any HIV medicines before, except you may have used daily oral PrEP (pre‑exposure prophylaxis) or PEP (post‑exposure prophylaxis) for up to one month before the screening visit.
  • You must be an adult (generally 18 years or older) and can be either male or female.

Who cannot join the trial?

2 criteria

  • Prior use or exposure to LEN (lenacapavir) or GS‑3242 – you cannot have taken these study medicines before the trial.
  • Prior use of any long‑acting injectable HIV medicines – this includes any medication given by injection that stays in the body for a long time, such as monoclonal antibodies (lab‑made proteins that target HIV), broadly neutralizing antibodies (special antibodies that work against many HIV strains), injectable cabotegravir (including any short oral “lead‑in” dose), or injectable rilpivirine.
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Investigated drugs

  • Biktarvy

    is a once‑daily pill that contains three approved HIV medicines (bictegravir, emtricitabine, and tenofovir alafenamide). In this study it is used as the standard treatment to compare the new drugs against.

  • GS-3242

    is an investigational medication being tested for HIV. It is given as an injection (in a liquid suspension) and also available as a tablet. The trial examines whether GS‑3242, when combined with another new drug, can safely and effectively control the virus.

  • Lenacapavir

    is a new type of HIV medicine that works in a different way from existing drugs. In the trial it is administered both by intravenous infusion and as an oral tablet. It is studied together with GS‑3242 to see if the combination can provide strong viral suppression.

  • Sunlenca

    is the brand name for the oral tablet form of lenacapavir. This tablet allows the medication to be taken by mouth, and in the study it is used in combination with GS‑3242 as part of the experimental treatment regimen.

What is already known about the treatment

  • Biktarvy 50 mg/200 mg/25 mg film-coated tablets

    This medication is taken by mouth as a film‑coated tablet. It is a widely used, approved treatment for HIV‑1 infection and is listed in many medical guidelines. The drug combines bictegravir, emtricitabine, and tenofovir alafenamide to stop the virus from copying its genetic material. It belongs to the class of integrase strand transfer inhibitors combined with nucleoside reverse transcriptase inhibitors.

  • GS‑3242

    GS‑3242 can be given either as an oral suspension or as a tablet that is swallowed. It is an investigational drug still being studied in clinical trials for HIV‑1 therapy. The compound works by blocking a key enzyme that the virus needs to mature and infect new cells. It is classified as a novel capsid inhibitor.

  • Lenacapavir

    Lenacapavir is administered intravenously as a clear solution for injection. It is a newly approved medication for HIV‑1 and is also being examined in ongoing studies. The drug binds to the viral capsid, preventing the virus from assembling and entering cells. It is categorized as a capsid assembly inhibitor.

  • Sunlenca 300 mg film-coated tablets

    Sunlenca is taken by mouth as a film‑coated tablet. It contains the same active ingredient, lenacapavir, and has received regulatory approval for treating HIV‑1 infection. The tablet works by the same capsid‑binding mechanism that stops the virus from replicating. It falls under the class of capsid assembly inhibitors.

Investigated diseases

HIV-1 infection - HIV-1 infection is a viral disease that targets the immune system, especially CD4 T‑lymphocytes. The virus enters these cells, replicates, and gradually reduces their numbers. Over months to years, the continual loss of CD4 cells weakens the body’s ability to fight other infections. The virus remains in the body for life, integrating its genetic material into host cells and persisting despite the immune response.
Trial detailsLast updated 12 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2026-526026-40-00Protocol codeGS-US-643-6557Estimated enrolment553 patientsSponsorGilead Sciences Inc.

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