A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects
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
Sponsor: Janssen Sciences Ireland UC
Listed as NCT02431247, this PHASE3 trial focuses on Immunodeficiency Virus Type 1, Human and remains completed. Sponsored by Janssen Sciences Ireland UC, it has been updated 34 times since 2015, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
34 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Sep 2022 — Jul 2024 [monthly]
Completed PHASE3
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Jan 2022 — Sep 2022 [monthly]
Completed PHASE3
▶ Show 29 earlier versions
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Jan 2021 — Jan 2022 [monthly]
Completed PHASE3
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Dec 2020 — Jan 2021 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Oct 2020 — Dec 2020 [monthly]
Active Not Recruiting PHASE3
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Sep 2020 — Oct 2020 [monthly]
Active Not Recruiting PHASE3
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Aug 2020 — Sep 2020 [monthly]
Active Not Recruiting PHASE3
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Jul 2020 — Aug 2020 [monthly]
Active Not Recruiting PHASE3
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Jun 2020 — Jul 2020 [monthly]
Active Not Recruiting PHASE3
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Dec 2019 — Jun 2020 [monthly]
Active Not Recruiting PHASE3
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Nov 2019 — Dec 2019 [monthly]
Active Not Recruiting PHASE3
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Sep 2019 — Nov 2019 [monthly]
Active Not Recruiting PHASE3
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Aug 2019 — Sep 2019 [monthly]
Active Not Recruiting PHASE3
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Jul 2019 — Aug 2019 [monthly]
Active Not Recruiting PHASE3
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Jun 2019 — Jul 2019 [monthly]
Active Not Recruiting PHASE3
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May 2019 — Jun 2019 [monthly]
Active Not Recruiting PHASE3
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Apr 2019 — May 2019 [monthly]
Active Not Recruiting PHASE3
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Feb 2019 — Apr 2019 [monthly]
Active Not Recruiting PHASE3
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Oct 2018 — Feb 2019 [monthly]
Active Not Recruiting PHASE3
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Aug 2018 — Oct 2018 [monthly]
Active Not Recruiting PHASE3
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Jul 2018 — Aug 2018 [monthly]
Active Not Recruiting PHASE3
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Jun 2018 — Jul 2018 [monthly]
Active Not Recruiting PHASE3
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Mar 2018 — Jun 2018 [monthly]
Active Not Recruiting PHASE3
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Dec 2017 — Mar 2018 [monthly]
Active Not Recruiting PHASE3
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Oct 2017 — Dec 2017 [monthly]
Active Not Recruiting PHASE3
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Sep 2017 — Oct 2017 [monthly]
Active Not Recruiting PHASE3
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May 2017 — Sep 2017 [monthly]
Active Not Recruiting PHASE3
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Apr 2017 — May 2017 [monthly]
Active Not Recruiting PHASE3
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Mar 2017 — Apr 2017 [monthly]
Active Not Recruiting PHASE3
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Feb 2017 — Mar 2017 [monthly]
Active Not Recruiting PHASE3
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE3
First recorded
Jul 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Janssen Sciences Ireland UC
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Alicante, Spain , Antwerp, Belgium , Badalona, Spain , Bakersfield, United States , Barcelona, Spain , Berkley, United States , Berlin, Germany , Birmingham, United States , Bonn, Germany , Boston, United States and 70 more locations