A Phase 3, randomized, active-controlled, double-blind study to evaluate efficacy and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once daily fixed dose combination regimen versus a regimen consisting of darunavir/cobicistat fixed dose combination coadministered with emtricitabine/tenofovir disoproxil fumarate fixed dose combination in antiretroviral treatment-naïve human immunodeficiency virus type 1 infected subjects. (TMC114FD2HTX3001)
The AMBER study is a phase 3, randomized, active controlled, double blind study. Its purpose is to evaluate the efficacy and safety of a once-daily fixed dose combination treatment in patients who have not previously received treatment for their HIV-1.
There is a screening visit followed by eight clinic visits over 48 weeks. Participants are randomised in a 1:1 ratio to one of the two treatment groups.
After Week 48, patients will continue to take their study drug in a blinded way and attend visits every 12 weeks until all patients have reached Week 48, the database for the primary analysis has been locked, and the physicians are informed which treatment their patients received. Based on the results of the primary analysis all patients (both groups) will be offered treatment with the D/C/F/TAF fixed dose combination tablet treatment during an open-label single group treatment phase up to Week 96.
After 96 weeks patients may continue treatment in the extension phase in which all participants will be have the option to receive the experimental treatment D/C/F/TAF.
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