In short
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.
Key points
- Clinical trials of Gs-4182 are being done in people with HIV-1 infection. One study is for people who already have viral suppression, and another is for people who have not been treated before. Both trials are Phase 4 studies and compare weekly oral Gs-1720 plus Gs-4182 with Biktarvy. The main results focus on the number of people with HIV-1 RNA above or below 50 copies/mL at Week 24 and Week 48. These trials are looking at how well the study regimen works over time in different patient groups.
Clinical trials overview
Two interventional studies are investigating Gs-4182 in people with HIV-1 infection. Both studies test weekly oral regimens and compare them with Biktarvy, which is listed in the trial data as bictegravir/emtricitabine/tenofovir alafenamide.
Study populations
One trial includes people with HIV-1 who are virologically suppressed, meaning the virus is already well controlled in the blood. The other trial includes people with HIV-1 who are treatment-naive, which means they have not been treated for HIV-1 before.
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. 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.
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. The comparison treatment is Biktarvy, which is used as the active control in both trials.
In the first study, the Phase 2 part evaluates switching to oral weekly GS-1720 plus Gs-4182 versus continuing Biktarvy at Week 24. The Phase 3 part evaluates a fixed-dose combination tablet of GS-1720/GS-4182 versus Biktarvy at Week 48.
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. The Phase 3 part evaluates the fixed-dose combination tablet regimen versus Biktarvy at Week 48 in treatment-naive people.
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. This outcome checks how many people have virus levels at or above a set threshold, which helps show whether viral control is maintained.
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. This outcome shows how many people reach a low virus level after starting treatment.
Trial status and enrollment
The trial for people who are virologically suppressed is listed as Authorised and has an enrollment of 82 participants. The trial for people who have not been treated before is listed as Completed and has an enrollment of 675 participants.