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GS-1720

Clinical trials are studying GS-1720 in people with HIV-1 infection. These studies look at how well GS-1720 works, how safe it is, and how it compares with Biktarvy in people who have not been treated and in people whose HIV is already controlled.

Table of contents

Trial overview

Two interventional studies are investigating GS-1720 in people with HIV-1 infection.[1][2] Both studies compare GS-1720-based treatment with Biktarvy, which is the control treatment used in these trials.[1][2]

One study is in people who have not been treated for HIV-1 yet, and the other is in people who are already virologically suppressed.[1][2] Virologically suppressed means the virus is already kept at a low level in the blood.[2]

Who can participate

The first study includes treatment-naive people with HIV-1, meaning people who have not yet received treatment for HIV-1.[1] This study is designed to see whether a weekly oral GS-1720 and GS-4182 regimen can work well as an initial treatment option.[1]

The second study includes people with HIV-1 who are already virologically suppressed.[2] This study looks at whether people can switch to GS-1720 plus GS-4182 and still keep the virus controlled.[2]

Study design and phases

Both trials are listed as Phase 4 studies.[1][2] Phase 4 means the treatment is being studied in a later stage of research, with a focus on real-world use and continued evaluation.[1][2]

The first study includes Phase 2 and Phase 3 goals within its plan.[1] The second study also includes Phase 2 and Phase 3 goals within its plan.[2] In both studies, the research compares weekly oral GS-1720 plus GS-4182 with Biktarvy.[1][2]

Both studies are interventional, which means the researchers give a treatment and then measure the results.[1][2]

What the trials measure

The main result in the first study is the proportion of participants with HIV-1 RNA less than 50 copies/mL at Week 24 in Phase 2, and at Week 48 in Phase 3.[1] This is a standard way to check whether the virus is strongly controlled.[1]

The main result in the second study is the proportion of participants with HIV-1 RNA at 50 copies/mL or higher at Week 24 in Phase 2, and at Week 48 in Phase 3.[2] This helps show whether people who switch treatment can stay suppressed.[2]

Both studies use the FDA-defined snapshot algorithm to judge these results.[1][2] This is a fixed method used in trials to measure success at a specific time point.[1][2]

Key trial comparisons

In the first study, oral weekly GS-1720 is given with GS-4182 and compared with Biktarvy in people who have not been treated for HIV-1.[1] The brief summary says the study looks at both a Phase 2 comparison at Week 24 and a Phase 3 comparison at Week 48.[1]

In the second study, people who are already suppressed are switched to oral weekly GS-1720 with GS-4182 and compared with continuing Biktarvy.[2] This study also looks at both Week 24 and Week 48 results.[2]

The trial data also lists GS-1720 as being studied as part of a fixed-dose combination tablet regimen in the first and second studies.[1][2] A fixed-dose combination means more than one medicine is combined into one tablet or regimen.[1][2]

Trial status and size

The first study, NCT2024-512505-66-00, is marked Completed and enrolled 675 people.[1] This is the larger of the two studies listed in the source data.[1]

The second study, NCT06544733, is marked Authorised and enrolled 82 people.[2] This study is smaller and focuses on people with controlled HIV-1 who may switch treatment.[2]

Trial ID Phase Condition studied Status Enrollment
2024-512505-66-00 Phase 4 HIV-1 infection in treatment-naive people Completed 675
NCT06544733 Phase 4 HIV-1 infection in virologically suppressed people Authorised 82

FAQ

  • What is being studied in the GS-1720 trials? The trials are studying oral weekly GS-1720, usually with GS-4182, in people with HIV-1. They compare this approach with Biktarvy to see how well it works.
  • Who can take part in these studies? One study includes people with HIV-1 who have not been treated yet. The other study includes people with HIV-1 who are already virologically suppressed, which means their virus is already controlled.
  • What phases are these trials? Both studies are Phase 4 trials. They also use Phase 2 and Phase 3 goals inside the same study plan to check results at different time points.
  • What do the trials measure? The main measure is the number of people whose HIV-1 RNA is below 50 copies/mL, or in one study, who stay at 50 copies/mL or above. This shows how well the treatment controls the virus.
  • How many people are in the GS-1720 studies? One completed study enrolled 675 people, and one authorised study enrolled 82 people. These numbers show the size of the study groups.

Ongoing Clinical Trials on GS-1720

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

    Not yet recruiting

    1 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

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

Glossary

  • HIV-1: A type of human immunodeficiency virus. It can weaken the immune system if it is not controlled.
  • Virologically suppressed: A term used when the amount of virus in the blood is very low or controlled.
  • HIV-1 RNA: A blood test that measures the amount of HIV genetic material. It helps show how active the virus is.
  • Copies/mL: A way to report virus level in blood. Lower numbers usually mean better control of the infection.
  • Snapshot algorithm: A standard method used in trials to judge treatment success at a certain time point.
  • Phase 4: A late-stage clinical trial done after a treatment is already being studied more widely.
  • Interventional study: A study where participants receive a treatment so researchers can compare results.
  • Treatment-naive: A person who has not yet received treatment for the condition being studied.
  • Fixed-dose combination: A tablet that contains two or more medicines in one dose.
  • Biktarvy: The treatment used as a comparison in both GS-1720 studies.

References