AMBER
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)
Project Summary
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.
Key Project Information
Dates: November 2015 - (ongoing)
Status: Current
UCL lead: Dr Laura Waters
Principal Investigator: Professor Chloe Orkin
Lead organisation: Janssen/Bart's Health Trust
Partners: Central and North West London NHS Foundation Trust
Location: Global
Funding: Janssen
Contact: mmc-research-cnwl@nhs.net
Dr Alejandro Arenas-Pinto
Dr Lewis Haddow
Dr Sarah Pett
Deidre Sally
Publications
Eron JJ, Orkin C, Gallant J, Molina JM, Negredo E, Antinori A, Mills A, Reynes J, Van Landuyt E, Lathouwers E, Hufkens V, Jezorwski J, Vanveggel S, Opsomer M; AMBER study group. A week-48 randomized phase-3 trial of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-naive HIV-1 patients. AIDS. 2018 Jul 17;32(11):1431-1442. doi: 10.1097/QAD.0000000000001817. PMID: 29683855; PMCID: PMC6039393.