Who is sponsoring NCT02269917?

NCT02269917 is sponsored by Janssen R&D Ireland.

What condition does NCT02269917 study?

NCT02269917 studies Human Immunodeficiency Virus Type 1.

What drugs are being tested in NCT02269917?

Interventions: D/C/F/TAF, Boosted Protease Inhibitor (bPI), FTC/TDF.

What is the status of NCT02269917?

NCT02269917 is currently COMPLETED.

Last reviewed 2021-11-25 · How we verify

A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

NCT02269917 Phase 3 COMPLETED Results posted

The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid \[HIV-1 RNA\] concentrations less than \[\<\] 50 copies per milliliter \[copies/mL\]) HIV-1 infected participants.

Details

Lead sponsor	Janssen R&D Ireland
Phase	Phase 3
Status	COMPLETED
Enrolment	1149
Start date	2015-03
Completion	2020-10

Conditions

Human Immunodeficiency Virus Type 1

Interventions

D/C/F/TAF
Boosted Protease Inhibitor (bPI)
FTC/TDF

Primary outcomes

Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48 — Through Week 48
Virologic rebound was defined as: confirmed plasma human immunodeficiency virus - 1 (HIV-1) Ribonucleic Acid (RNA) level greater than or equal to (\>=)50 copies per milliliter (copies/mL) up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA \>=50 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.

Countries

United States, Belgium, Canada, France, Poland, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom