Trial Profile
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-naive Human Immunodeficiency Virus Type 1 Infected Subjects
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 28 Mar 2023
Price :
$35
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At a glance
- Drugs Cobicistat/darunavir/emtricitabine/tenofovir alafenamide (Primary) ; Cobicistat/darunavir; Emtricitabine/tenofovir disoproxil fumarate
- Indications HIV-1 infections
- Focus Registrational; Therapeutic Use
- Acronyms AMBER
- Sponsors Janssen; Janssen Sciences Ireland UC
- 01 Mar 2023 Results of subgroup analysis from AMBER and EMERALD evaluating the prevalence of pre-existing neurological and/or psychiatric comorbidities (NPCs) and efficacy/safety outcomes for participants with versus without baseline, published in the HIV Medicine
- 26 Oct 2022 Results of pooled analysis assessing Long-term efficacy and resistance analyses of D/C/F/TAF in the phase III AMBER and EMERALD studies presented at the 16th International Congress on Drug Therapy and HIV Infection
- 04 Nov 2020 Status changed from active, no longer recruiting to completed.