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Gs-4182

Clinical trials are studying Gs-4182 in people with HIV-1 infection. These studies look at how well Gs-4182 works in weekly oral regimens compared with Biktarvy, and they measure virologic suppression in both people who are already suppressed and people who have not been treated before.

Table of Contents

Clinical trials overview

Two interventional studies are investigating Gs-4182 in people with HIV-1 infection.[1][2] Both studies test weekly oral regimens and compare them with Biktarvy, which is listed in the trial data as bictegravir/emtricitabine/tenofovir alafenamide.[1][2]

Study populations

One trial includes people with HIV-1 who are virologically suppressed, meaning the virus is already well controlled in the blood.[1] The other trial includes people with HIV-1 who are treatment-naive, which means they have not been treated for HIV-1 before.[2]

Trial design and phases

Both studies are listed as Phase 4 and are interventional trials, so the researchers are giving study treatments and watching what happens.[1][2] The trial plans also include Phase 2 and Phase 3 parts in the outcome descriptions, which means the studies measure results at earlier and later time points within the same research program.[1][2]

Treatments compared

In both studies, Gs-4182 is given with GS-1720 as a weekly oral regimen, meaning the medicine is taken by mouth once each week.[1][2] The comparison treatment is Biktarvy, which is used as the active control in both trials.[1][2]

In the first study, the Phase 2 part evaluates switching to oral weekly GS-1720 plus Gs-4182 versus continuing Biktarvy at Week 24.[1] The Phase 3 part evaluates a fixed-dose combination tablet of GS-1720/GS-4182 versus Biktarvy at Week 48.[1]

In the second study, the Phase 2 part evaluates oral weekly GS-1720 with Gs-4182 versus Biktarvy at Week 24 in treatment-naive people.[2] The Phase 3 part evaluates the fixed-dose combination tablet regimen versus Biktarvy at Week 48 in treatment-naive people.[2]

Main outcomes measured

The main outcome in the suppressed-population study is the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 for the Phase 2 part and at Week 48 for the Phase 3 part, using the US FDA-defined snapshot algorithm.[1] This outcome checks how many people have virus levels at or above a set threshold, which helps show whether viral control is maintained.[1]

The main outcome in the treatment-naive study is the proportion of participants with HIV-1 RNA < 50 copies/mL at Week 24 for the Phase 2 part and at Week 48 for the Phase 3 part, also using the US FDA-defined snapshot algorithm.[2] This outcome shows how many people reach a low virus level after starting treatment.[2]

Trial status and enrollment

The trial for people who are virologically suppressed is listed as Authorised and has an enrollment of 82 participants.[1] The trial for people who have not been treated before is listed as Completed and has an enrollment of 675 participants.[2]

Trial ID Phase Condition studied Status Enrollment
NCT06544733 Phase 4 HIV-1 Infection Authorised 82
2024-512505-66-00 Phase 4 HIV-1 Infection Completed 675

FAQ

  • What is being studied in the Gs-4182 trials? The trials are studying Gs-4182 as part of a weekly oral treatment plan for HIV-1 infection. It is tested with GS-1720 and compared with Biktarvy.
  • Who can take part in these studies? One study includes people with HIV-1 who are already virologically suppressed, meaning the virus is already at a low level. The other study includes people with HIV-1 who have not been treated before.
  • What phase are the Gs-4182 trials? Both studies are Phase 4 trials. They also include Phase 2 and Phase 3 parts in their outcome plans.
  • What results are the trials measuring? The studies measure the number of participants with HIV-1 RNA above or below 50 copies/mL at Week 24 and Week 48. This shows how well the treatment keeps the virus under control.
  • Are the trials comparing Gs-4182 with another treatment? Yes. Both trials compare the weekly Gs-1720 and Gs-4182 regimen with Biktarvy. This helps show whether the study regimen works as well as the current standard treatment.

Ongoing Clinical Trials on Gs-4182

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

    Not yet recruiting

    4 1 1 1
    Investigated drugs:
    France Germany Italy Poland Spain Sweden

  • Study of Weekly Oral GS-1720 and GS-4182 for Untreated HIV-1 Patients

    Not recruiting

    4 1 1 1
    Investigated drugs:
    Germany Poland Portugal Romania Spain

Glossary

  • HIV-1 infection: An infection caused by the HIV-1 virus, which attacks the immune system.
  • Virologically suppressed: A state where the amount of virus in the blood is very low or controlled.
  • Treatment-naive: A person who has not received treatment for the condition before.
  • Interventional study: A clinical trial where researchers give a treatment and measure what happens.
  • Phase 4: A later stage of clinical research that studies a treatment in people after earlier testing.
  • Phase 2: A study stage that looks more closely at how well a treatment works.
  • Phase 3: A study stage that compares a treatment with another treatment in a larger group.
  • Primary outcome: The main result the researchers want to measure in a trial.
  • HIV-1 RNA: The amount of HIV-1 genetic material in the blood; it is used to measure how active the virus is.
  • Snapshot algorithm: A standard method used to judge trial results at a set time point.
  • Week 24: The result check done 24 weeks after the study starts.
  • Week 48: The result check done 48 weeks after the study starts.

References