In short
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.
Key points
- Clinical trials of GS-1720 are studying people with HIV-1 infection. One trial includes people who have not been treated yet, and another includes people whose HIV is already virologically suppressed. Both studies compare GS-1720, usually with GS-4182, against Biktarvy. The trials are Phase 4 studies, and they measure how many participants reach or keep HIV-1 RNA at very low levels. One study is completed, and the other is authorised.
Trial overview
Two interventional studies are investigating GS-1720 in people with HIV-1 infection. Both studies compare GS-1720-based treatment with Biktarvy, which is the control treatment used in these trials.
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. Virologically suppressed means the virus is already kept at a low level in the blood.
Who can participate
The first study includes treatment-naive people with HIV-1, meaning people who have not yet received treatment for HIV-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.
The second study includes people with HIV-1 who are already virologically suppressed. This study looks at whether people can switch to GS-1720 plus GS-4182 and still keep the virus controlled.
Study design and phases
Both trials are listed as Phase 4 studies. Phase 4 means the treatment is being studied in a later stage of research, with a focus on real-world use and continued evaluation.
The first study includes Phase 2 and Phase 3 goals within its plan. The second study also includes Phase 2 and Phase 3 goals within its plan. In both studies, the research compares weekly oral GS-1720 plus GS-4182 with Biktarvy.
Both studies are interventional, which means the researchers give a treatment and then measure the results.
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. This is a standard way to check whether the virus is strongly controlled.
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. This helps show whether people who switch treatment can stay suppressed.
Both studies use the FDA-defined snapshot algorithm to judge these results. This is a fixed method used in trials to measure success at a specific time point.
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. The brief summary says the study looks at both a Phase 2 comparison at Week 24 and a Phase 3 comparison at Week 48.
In the second study, people who are already suppressed are switched to oral weekly GS-1720 with GS-4182 and compared with continuing Biktarvy. This study also looks at both Week 24 and Week 48 results.
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. A fixed-dose combination means more than one medicine is combined into one tablet or regimen.
Trial status and size
The first study, NCT2024-512505-66-00, is marked Completed and enrolled 675 people. This is the larger of the two studies listed in the source data.
The second study, NCT06544733, is marked Authorised and enrolled 82 people. This study is smaller and focuses on people with controlled HIV-1 who may switch treatment.