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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment- Naive Adults

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Trial Profile

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment- Naive Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2021

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At a glance

  • Drugs Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide (Primary) ; Elvitegravir/emtricitabine/tenofovir disoproxil fumarate/cobicistat
  • Indications HIV-1 infections
  • Focus Registrational; Therapeutic Use
  • Acronyms Study 111
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 14 Oct 2019 Results of pooled analysis from 8 phase III trials (CTP 4999, 55400,55093,195806,228352,229699,263351 and 263352 )published in the Clinical Infectious Diseases
    • 07 Mar 2019 Results of a pooled analysis of 7 randomized, double-blind clinical trials assessing the efficacy and safety of TAF vs. TDF for ART initiation or switch in women, presented at the 26th Conference on Retroviruses and Opportunistic Infections
    • 04 Dec 2018 According to a Gilead Sciences media release, the China National Medical Products Administration (NMPA) has approved Descovy (emtricitabine 200 mg/tenofovir alafenamide 10 mg and emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), in combination with other antiretroviral agents for the treatment of HIV-1 in adults and adolescents (aged 12 years and older with body weight at least 35 kg) and is supported by 144-week data from Studies 104 and 111 and 109.
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