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Completed Phase 3 Interventional Results available

Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants

ClinicalTrials.gov ID: NCT02269917

Public ClinicalTrials.gov record NCT02269917. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 9:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02269917
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen R&D Ireland
Industry
Enrollment
1,149 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2015 (Actual)
Primary completion
Feb 2017 (Actual)
Completion
Oct 2020 (Actual)
Last update posted
Dec 9, 2021

2015 – 2020

United States locations

U.S. sites
38
U.S. states
19
U.S. cities
38
Facility City State ZIP Site status
Not listed Phoenix Arizona — —
Not listed Bakersfield California — —
Not listed Beverly Hills California — —
Not listed Long Beach California — —
Not listed Los Angeles California — —
Not listed San Diego California — —
Not listed San Francisco California — —
Not listed Washington D.C. District of Columbia — —
Not listed Fort Lauderdale Florida — —
Not listed Ft. Pierce Florida — —
Not listed Orlando Florida — —
Not listed West Palm Beach Florida — —
Not listed Atlanta Georgia — —
Not listed Savannah Georgia — —
Not listed Chicago Illinois — —
Not listed Boston Massachusetts — —
Not listed Springfield Massachusetts — —
Not listed Berkley Michigan — —
Not listed Detroit Michigan — —
Not listed Minneapolis Minnesota — —
Not listed Kansas City Missouri — —
Not listed St Louis Missouri — —
Not listed Hillsborough New Jersey — —
Not listed Newark New Jersey — —
Not listed Somers Point New Jersey — —
Not listed Santa Fe New Mexico — —
Not listed New York New York — —
Not listed Chapel Hill North Carolina — —
Not listed Winston-Salem North Carolina — —
Not listed Cincinnati Ohio — —
Not listed Philadelphia Pennsylvania — —
Not listed Providence Rhode Island — —
Not listed Austin Texas — —
Not listed Dallas Texas — —
Not listed Fort Worth Texas — —
Not listed Houston Texas — —
Not listed Longview Texas — —
Not listed Seattle Washington — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02269917, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 9, 2021 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02269917 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →