A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain
NCT ID: NCT04442737
Last Updated: 2025-03-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
103 participants
INTERVENTIONAL
2020-07-01
2023-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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
NCT02431247
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
NCT03227861
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
NCT02269917
Early Metabolic Effects of Dolutegravir or Tenofovir Alefenamide in Healthy Volunteers
NCT05652478
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
NCT01968551
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
D/C/F/TAF FDC Arm (Immediate Switch)
Participants will be immediately switched to a regimen of darunavir 800 milligram (mg)/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily for 48 weeks.
D/C/F/TAF FDC
A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.
INI + TAF/FTC Arm (Delayed Switch)
Participants will continue to receive current baseline integrase (INI)-based regimen plus Tenofovir Alafenamide/Emtricitabine (TAF/FTC) antiretroviral (ARV) regimen for 24 weeks. After 24 weeks participants will switch to a regimen of D/C/F/TAF FDC once daily for an additional 24 weeks.
D/C/F/TAF FDC
A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.
TAF/FTC FDC
TAF/FTC ARV regimen will be administered once daily.
INI Based Regimen
The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate. Regimen may consist of a single tablet regimen or a combination of two separate pills.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
D/C/F/TAF FDC
A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.
TAF/FTC FDC
TAF/FTC ARV regimen will be administered once daily.
INI Based Regimen
The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate. Regimen may consist of a single tablet regimen or a combination of two separate pills.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented human immunodeficiency virus (HIV)-1 infection
* Currently being treated with a stable ARV regimen consisting of an INI combined with TAF/FTC for \>=6 consecutive months preceding the screening visit and experienced a \>=10 percent (%) increase in body weight within a 36-month time period prior to screening and while on the current INI + TAF/FTC ARV regimen
* Documented evidence of being virologically suppressed while on the current stable INI+TAF/FTC ARV regimen prior to screening
* At least one plasma HIV-1 RNA measurement less than (\<) 50 copies/milliliter (mL) occurring between 12 and 2 months prior to the screening visit while on the stable INI+ TAF/FTC ARV regimen and have HIV-1 RNA \<50 copies/ mL at the screening visit
Exclusion Criteria
* Known allergies, hypersensitivity, or intolerance to D/C/F/TAF fixed-dose combination (FDC) tablet or its excipients
* Active hepatitis B (HBV) or hepatitis C virus (HCV) infection
* Uncontrolled diabetes that will require treatment with insulin during the study period
* Evidence of Child Pugh Class C based on clinical laboratory testing and clinical evaluation
* History of failure on darunavir (DRV) treatment or known documented history of \>=1 DRV resistance-associated mutations (RAM)
* Screening hepatic transaminases \>5x the upper limit of the normal range
* Screening creatinine based estimated glomerular filtration rate (eGFRcr) \<30 ml/min according to the Cockcroft-Gault formula for creatinine clearance
* Participants initiating or discontinuing concomitant medications associated with significant changes in weight within the last 90 days
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
The Office of Franco Felizarta, MD
Bakersfield, California, United States
AIDS Health Foundation-Westside HCC
Beverly Hills, California, United States
Long Beach Education & Research Consultants
Long Beach, California, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
University of Miami
Miami, Florida, United States
Triple O Research Institute
West Palm Beach, Florida, United States
Atlanta ID Group
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
The Corporation of Mercer University
Macon, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
The Ruth M. Rothstein CORE Center
Chicago, Illinois, United States
Care South Clinic
Baton Rouge, Louisiana, United States
Kaiser Permanente
Rockville, Maryland, United States
Community Research Initiative
Boston, Massachusetts, United States
Be Well Medical Center, PC
Berkley, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University School Of Medicine
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Saint Michaels Medical Center - Infectious Disease
Newark, New Jersey, United States
AIDS Healthcare Foundation-Research Center
New York, New York, United States
Mount Sinai Hospital-New York
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Philadelphia Fight
Philadelphia, Pennsylvania, United States
Palmetto Health - USC
Columbia, South Carolina, United States
AIDS Arms Incorporated Trinity Health and Wellness Center
Dallas, Texas, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States
Therapeutic Concepts - Donald R Watkins Foundation
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Infectious Disease Associates of Central Virginia
Lynchburg, Virginia, United States
Vivent Health
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Anderson D, Ramgopal M, Hagins DP, Lee J, Simonson RB, Hsu TH, Xu P, Ahmad N, Short WR. DEFINE: A Prospective, Randomized, Phase 4 Trial to Assess a Protease Inhibitor-Based Regimen Switch Strategy to Manage Integrase Inhibitor-Related Weight Gain. Clin Infect Dis. 2025 Mar 17;80(3):602-612. doi: 10.1093/cid/ciae449.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TMC114FD2HTX4004
Identifier Type: OTHER
Identifier Source: secondary_id
CR108757
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.