HIV-1Phase 4DEFINENCT04442737
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
A Phase 4 study testing D/C/F/TAF FDC, TAF/FTC FDC and INI Based Regimen in people with HIV-1, run by Janssen Scientific Affairs, LLC at 34 sites in United States.
Trial summary
The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir alafenamide/emtricitabine (TAF/FTC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1
- What is being tested?
- D/C/F/TAF FDC, TAF/FTC FDC and INI Based Regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 34 sitesUnited States
- Study dates
- 1 Jul 2020to 30 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) of greater than or equal to (>=) 18 kilogram per meter square (kg/m^2) at time of starting an integrase (INI)-based regimen plus Tenofovir Alafenamide/Emtricitabine (TAF/FTC) antiretroviral (ARV) regimen
- 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
Who cannot join
- Known history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Atlanta ID Group
Atlanta, Georgia, 30309
Medical College of Georgia
Augusta, Georgia, 30912
The Office of Franco Felizarta, MD
Bakersfield, California, 93301
Care South Clinic
Baton Rouge, Louisiana, 70806
Be Well Medical Center, PC
Berkley, Michigan, 48072
AIDS Health Foundation-Westside HCC
Beverly Hills, California, 90211
University of Alabama at Birmingham
Birmingham, Alabama, 35222
Community Research Initiative
Boston, Massachusetts, 02129
The Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612
Palmetto Health - USC
Columbia, South Carolina, 29203
AIDS Arms Incorporated Trinity Health and Wellness Center
Dallas, Texas, 75208
North Texas Infectious Diseases Consultants
Dallas, Texas, 75246
Henry Ford Health System
Detroit, Michigan, 48202
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, 76104
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
Therapeutic Concepts - Donald R Watkins Foundation
Houston, Texas, 77004
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Long Beach Education & Research Consultants
Long Beach, California, 90813
DCOL Center for Clinical Research
Longview, Texas, 75605
Infectious Disease Associates of Central Virginia
Lynchburg, Virginia, 24501
The Corporation of Mercer University
Macon, Georgia, 31201
University of Miami
Miami, Florida, 33136
Vivent Health
Milwaukee, Wisconsin, 53203
AIDS Healthcare Foundation-Research Center
New York, New York, 10001
Mount Sinai Hospital-New York
New York, New York, 10029
Saint Michaels Medical Center - Infectious Disease
Newark, New Jersey, 07102
University of Nebraska
Omaha, Nebraska, 68106
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Philadelphia Fight
Philadelphia, Pennsylvania, 19107
Kaiser Permanente
Rockville, Maryland, 20852
Chatham County Health Department
Savannah, Georgia, 31401
Washington University School Of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
Triple O Research Institute
West Palm Beach, Florida, 33407
About this study
Official title: A Phase 4, Randomized, Active-Controlled, Open-label Study to Evaluate the Safety and Tolerability of Switching to Once-Daily Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Regimen in Virologically-suppressed Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Experiencing Rapid Weight Gain With an INI + TAF/FTC ARV Regimen
The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir alafenamide/emtricitabine (TAF/FTC) antiretroviral (ARV) regimen (Delayed Switch Arm) in virologically-suppressed human immunodeficiency virus (HIV)-1 infected participants who have experienced rapid and significant body weight gain.
- Conditions
- HIV-1
- Being tested
- D/C/F/TAF FDC, TAF/FTC FDC, INI Based Regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D/C/F/TAF FDCDrug
A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.
TAF/FTC FDCDrug
TAF/FTC ARV regimen will be administered once daily.
INI Based RegimenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| D/C/F/TAF FDC Arm (Immediate Switch) | Experimental | 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. Receives: Drug: D/C/F/TAF FDC |
| INI + TAF/FTC Arm (Delayed Switch) | Active comparator | 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. Receives: Drug: D/C/F/TAF FDC; Drug: TAF/FTC FDC; Drug: INI Based Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Body Weight at Week 24
Percent change from baseline in body weight at Week 24 were reported.
Measured: Baseline and Week 24
Percent Change From Baseline in Body Weight at Week 24: Body Mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) Subgroup
Percent change from baseline in body weight at Week 24 in BMI >=30 kilograms per square meter (kg/m^2) subgroup were reported.
Measured: Baseline and Week 24
Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup
Percent change from baseline in body weight at Week 24 in female and male subgroup were reported.
Measured: Baseline and Week 24
Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups
Percent change from baseline in body weight at Week 24 in Black/African American and Black/African American- Female subgroups were reported.
Measured: Baseline and Week 24
Percent Change From Baseline in Body Weight at Week 24: Non-Black/African American Subgroup
Percent change from baseline in body weight at Week 24 in Non-Black/African American subgroup were reported.
Measured: Baseline and Week 24
Secondary outcomes (41)
Change From Baseline in Absolute Body Weight Over Time
Change from baseline in absolute body weight over time were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
Percentage of participants with change from baseline >=3% to <= 5% in body weight over time was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
Percentage of participants with change from baseline >5% in body weight over time was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Change From Baseline in Body Mass Index (BMI) Over Time
Change from baseline in BMI over time was reported. BMI was calculated as weight (kg)/(height (m^2).
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Change from baseline in body composition as measured by (DEXA) scan at Weeks 24 and 48 was reported. Body composition included Mass of Fat for Trunk, Lean Body Mass for Trunk, total Mass for Trunk, Mass of Fat for Total Body, Lean Body Mass for Total Body, Total Mass for Total Body, Mass of Fat for Adjusted Total Body, Lean Body Mass for Adjusted Total Body, Total Mass for Adjusted Total Body, Mass of Fat for Appendages, Lean Body Mass for Appendages, total Mass for Appendages, Mass of Visceral Adipose Tissue, and Volume of Visceral Adipose Tissue. Adjusted refers to not including participant's head.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Waist Circumference Over Time
Change from baseline in waist circumference over time was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
Change from baseline in SBP and DBP over time was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Change from baseline in fasting lipids at Weeks 24 and 48 was reported. Fasting lipids included: fasting total cholesterol, fasting high-density lipoprotein (HDLs) and low-density lipoprotein (LDLs), and fasting triglycerides.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Fasting Glucose at Weeks 24 and 48
Change from baseline in fasting glucose at Weeks 24 and 48 was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48
Change from baseline in HOMA-IR at Weeks 24 and 48 was reported. HOMA-IR is calculated as fasting insulin * fasting glucose divided by 405.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48
Change from baseline in percent of HbA1c at Weeks 24 and 48 was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Leptin at Weeks 24 and 48
Change from baseline in leptin at Weeks 24 and 48 was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Adiponectin at Weeks 24 and 48
Change from baseline in adiponectin at Weeks 24 and 48 was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48
Percentage of participants with advanced fibrosis as assessed by NAFLD fibrosis score at Week 24 and 48 was reported. The NAFLD is based on a combination of clinical and laboratory measurements (that is, age, glycemia, BMI, platelet, albumin and AST/ALT ratio). The set cutoffs for this scoring are: NAFLD Score <-1.455 = F0-F2 (negative), NAFLD Score -1.455 to 0.675 = indeterminate score, NAFLD Score >0.675 = F3 - F4 (positive). NAFLD score was calculated as: 1.675 + 0.037 * age (years) + 0.094 * BMI (kg/m^2) + 1.13 * Impaired Fasting Glucose or Diabetes (yes =1; no=0) + 0.99 * AST/ALT ratio minus 0.013 * platelet (10^9/L) minus 0.66 * albumin (g/dL).
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48
Percentage of participants at high risk of NASH according to the HAIR score at Weeks 24 and 48 was reported. HAIR score (0-3) is calculated by adding Hypertension = 1, alanine aminotransferase (ALT) >40 international unit (IU)=1, and Insulin resistance index (IR) >5.0 = 1. A score of >=2 is considered as high risk for NASH.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Percentage of participants with a dose-reduction or complete withdrawal of anti-hypertensive, anti-hyperglycemic, or lipid lowering agents were reported.
Measured: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Percentage of participants initiating an anti-hypertensive, anti-hyperglycemic, or lipid lowering agents were reported.
Measured: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)
Number of participants with any grade TEAEs was reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention.
Measured: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Number of Participants With Grade 3 and Grade 4 TEAEs
Number of participants with Grade 3 and Grade 4 TEAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention. Grades were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table: Grade 1: mild event; Grade 2: moderate event; Grade 3: severe event; Grade 4: potentially life-threatening event; Grade 5: death. Higher grades indicated worsening of TEAEs.
Measured: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Number of Participants Who Discontinued the Study Drug Due to TEAEs
Number of participants who discontinued the study drug due to TEAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were those AE events that occurred at or after the initial administration of study intervention.
Measured: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Number of participants with treatment-emergent SAEs were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Treatment-emergent SAEs were those SAE events that occurred at or after the initial administration of study intervention.
Measured: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48
Change from baseline in biochemistry parameters: albumin and protein values at Weeks 24 and 48 were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48
Change from baseline in biochemistry parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase values at Weeks 24 and 48 were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Change from baseline in biochemistry parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen values at Weeks 24 and 48 were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Change from baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (segmented), Platelets, and Leukocytes values at Weeks 24 and 48 were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48
Change from baseline in hematology parameter: hemoglobin values at Weeks 24 and 48 were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48
Change from baseline in hematology parameter: Erythrocytes values at Weeks 24 and 48 were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48
Change from baseline in urinalysis parameter (specific gravity) values at Weeks 24 and 48 were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48
Change from baseline in urinalysis parameter: pH values at Weeks 24 and 48 were reported. The pH scale measures how acidic or alkaline a substance is. The scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Higher the pH value, more alkaline is the substance.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities
Number of participants with grade 3 and grade 4 laboratory abnormalities were reported. Grades were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table: Grade 1: mild ; Grade 2: moderate ; Grade 3: severe ; Grade 4: potentially life-threatening ; Grade 5: death. Higher grades indicated worsening of abnormalities.
Measured: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48
Percentage of participants with confirmed virologic rebound at Weeks 24 and 48 was reported. Virologic rebound defined as when 2 consecutive HIV-1 RNA values >=200 copies/mL at a scheduled or unscheduled visit.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48
Percentage of participants with virologic response (HIV-1 RNA<50 copies/mL) at Weeks 24 and 48 was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48
Percentage of participants with virologic failure (HIV-1 RNA >=50 copies/mL) at Weeks 24 and 48 was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48
Percentage of participants with virologic response (HIV-1 RNA<200 copies/mL) at Week 24 and 48 was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48
Percentage of participants with virologic failure (HIV-1 RNA >=200 copies/mL) at Weeks 24 and 48 was reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48
Change from baseline in CD4+ cell count at Weeks 24 and 48 were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Percentage of participants who had bothersome symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 were reported. HIV-SI is a validated PRO instrument to assess 20 common HIV symptoms: fatigue/loss of energy, difficulty sleeping, nervous/anxious, diarrhea/loose bowels, changes in body composition, feeling sad/down/depressed, bloating/pain/gas in stomach, muscle aches/joint pain, problems with sex, trouble remembering, headaches, pain/numbness/tingling in hands/feet, skin problems/rash/itching, cough/trouble breathing, fever/chills/sweats, dizzy/lightheadedness, body weight loss/wasting, nausea/vomiting, hair loss/changes, and loss of appetite/food taste. Symptoms were rated using a 5-point Likert scale: 0: I don't have this symptom; 1: I have this symptom and it doesn't bother me; 2: I have this symptom and it bothers me a little; 3: I have this symptom and it bothers me; 4: I have this symptom and it bothers me a lot. Higher score refers more symptoms.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Percentage of participants who had any symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 were reported. HIV-SI is a validated PRO instrument to assess 20 common HIV symptoms: fatigue/loss of energy, difficulty sleeping, nervous/anxious, diarrhea/loose bowels, changes in body composition, feeling sad/down/depressed, bloating/pain/gas in stomach, muscle aches/joint pain, problems with sex, trouble remembering, headaches, pain/numbness/tingling in hands/feet, skin problems/rash/itching, cough/trouble breathing, fever/chills/sweats, dizzy/lightheadedness, body weight loss/wasting, nausea/vomiting, hair loss/changes, and loss of appetite/food taste. Symptoms were rated using a 5-point Likert scale: 0: I don't have this symptom; 1: I have this symptom and it doesn't bother me; 2: I have this symptom and it bothers me a little; 3: I have this symptom and it bothers me; 4: I have this symptom and it bothers me a lot. Higher score refers more symptoms.
Measured: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48
Number of participants With each bothersome symptom of the HIV-SI adjusting for baseline variables at Weeks 24 and 48 were reported.
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Percentage of participants with PGIC scale score at Weeks 24 and 48 were reported. The PGI-C was a patient reported outcome (PRO) where participants rated using a 7-point scale ranging from 1 to 7 where 1 indicates "very much improved", 2 indicates "much improved', 3 indicates "minimally improved", 4 indicates "No change", 5 indicates "minimally worse", 6 indicates "Much worse" and 7 indicates "Very much worse".
Measured: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Adherence Rate to Treatment at Weeks 4, 12, 24, 36, and 48
Adherence rate to treatment at Weeks 4, 12, 24, 36 and 48 were reported. Adherence rates were reported according to the percentage of participants missing 0, 1, 2, 3 or 4 doses as 100%, 75%, 50%, 25%, and 0%, respectively, using participant self-report 4-day recall at Weeks 4, 12, 24, 36, and 48.
Measured: Weeks 4, 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jul 2020
- Primary completion7 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442737
- Sponsor's protocol ID
- CR108757
- Other IDs
- TMC114FD2HTX4004
- Acronym
- DEFINE
- Status last verified
- Mar 2025
- First submitted
- 3 Jun 2020
- Last updated
- 30 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Publications
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.
PubMed 39230668
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Active-Controlled, Open-label Study to Evaluate the Safety and Tolerability of Switching to Once-Daily Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Regimen in Virologically-suppressed Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Experiencing Rapid Weight Gain With an INI + TAF/FTC ARV Regimen
- ClinicalTrials.gov ID
- NCT04442737
- Acronym / sponsor ID
- DEFINE / CR108757
- Conditions
- HIV-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Posted 27 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) (Immediate Switch Arm) compared to continuing the current integrase (INI) + tenofovir alafenamide/emtricitabine (TAF/FTC) antiretroviral (ARV) regimen (Delayed Switch Arm) in virologically-suppressed human immunodeficiency virus (HIV)-1 infected participants who have experienced rapid and significant body weight gain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D/C/F/TAF FDC Arm (Immediate Switch) | Experimental | Drug: D/C/F/TAF FDCParticipants 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. |
| INI + TAF/FTC Arm (Delayed Switch) | Active comparator | Drug: D/C/F/TAF FDC, Drug: TAF/FTC FDC, Drug: INI Based RegimenParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) of greater than or equal to (>=) 18 kilogram per meter square (kg/m^2) at time of starting an integrase (INI)-based regimen plus Tenofovir Alafenamide/Emtricitabine (TAF/FTC) antiretroviral (ARV) regimen
- 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
Key exclusion criteria (9 listed)
- Known history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D/C/F/TAF FDCA FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily. | Drug | D/C/F/TAF FDC Arm (Immediate Switch), INI + TAF/FTC Arm (Delayed Switch) |
| TAF/FTC FDCTAF/FTC ARV regimen will be administered once daily. | Drug | INI + TAF/FTC Arm (Delayed Switch) |
| INI Based RegimenThe 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. | Drug | INI + TAF/FTC Arm (Delayed Switch) |
Primary outcome
Percent Change From Baseline in Body Weight at Week 24
Time frame: Baseline and Week 24
Percent change from baseline in body weight at Week 24 were reported.
Percent Change From Baseline in Body Weight at Week 24: Body Mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) Subgroup
Time frame: Baseline and Week 24
Percent change from baseline in body weight at Week 24 in BMI >=30 kilograms per square meter (kg/m^2) subgroup were reported.
Percent Change From Baseline in Body Weight at Week 24: Female and Male Subgroup
Time frame: Baseline and Week 24
Percent change from baseline in body weight at Week 24 in female and male subgroup were reported.
Percent Change From Baseline in Body Weight at Week 24: Black/African American and Black/African American- Female Subgroups
Time frame: Baseline and Week 24
Percent change from baseline in body weight at Week 24 in Black/African American and Black/African American- Female subgroups were reported.
Percent Change From Baseline in Body Weight at Week 24: Non-Black/African American Subgroup
Time frame: Baseline and Week 24
Percent change from baseline in body weight at Week 24 in Non-Black/African American subgroup were reported.
41 secondary outcomes
Change From Baseline in Absolute Body Weight Over Time
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Percentage of Participants With Change From Baseline Greater Than or Equal to (>=) 3% to <= 5% in Body Weight Over Time
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Percentage of Participants With Change From Baseline Greater Than (>) 5 Percent (%) in Body Weight Over Time
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Change From Baseline in Body Mass Index (BMI) Over Time
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Change From Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Waist Circumference Over Time
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Baseline, Weeks 4, 12, 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 36 and 48
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Fasting Glucose at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Percent of Hemoglobin A1c (HbA1c) at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Leptin at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Adiponectin at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Percentage of Participants With Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants at High Risk of Non-alcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Percentage of Participants With a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Time frame: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents
Time frame: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Number of Participants With Any Grade Treatment-emergent Adverse Events (TEAEs)
Time frame: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Number of Participants With Grade 3 and Grade 4 TEAEs
Time frame: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Number of Participants Who Discontinued the Study Drug Due to TEAEs
Time frame: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Time frame: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Change From Baseline in Biochemistry Parameters: Albumin and Protein Values at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase, and Aspartate Aminotransferase Values at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Biochemistry Parameters: Bicarbonate, Calcium, Cholesterol, Chloride, Potassium, Phosphate, Sodium, Triglycerides, and Urea Nitrogen Values at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils (Segmented), Platelets, and Leukocytes Values at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Hematology Parameter: Hemoglobin Values at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Hematology Parameter: Erythrocytes Values at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Urinalysis Parameter: Specific Gravity Values at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Change From Baseline in Urinalysis Parameter: pH Values at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Number of Participants With Grade 3 and Grade 4 Laboratory Abnormalities
Time frame: D/C/F/TAF Immediate Switch (IS1) and INI + TAF/FTC Delayed Switch (DS1): Baseline up to Week 24; D/C/F/TAF Immediate Switch (IS2) and INI + TAF/FTC to D/C/F/TAF Delayed Switch (DS2): Week 25 up to Week 48
Percentage of Participants With Confirmed Virologic Rebound at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Virologic Response (HIV-1 RNA<50 Copies/mL) at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Virologic Failure (HIV-1 RNA >=50 Copies/mL) at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Virologic Response (HIV-1 RNA<200 Copies/mL) at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Virologic Failure (HIV-1 RNA >=200 Copies/mL) at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Percentage of Participants Who Had Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Percentage of Participants Who Had Any Symptoms (Scores of 1, 2, 3 or 4) Across All Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS1): Baseline, Week 24; D/C/F/TAF Immediate Switch (IS): Baseline, Week 48
Number of Participants With Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Percentage of Participants With Patient Global Impression of Change (PGIC) Scale Score at Weeks 24 and 48
Time frame: INI + TAF/FTC Delayed Switch (DS1) and D/C/F/TAF Immediate Switch (IS1): Week 24; D/C/F/TAF Immediate Switch (IS): Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39230668Anderson 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.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Related trials for HIV-1
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing D/C/F/TAF FDC, TAF/FTC FDC and INI Based Regimen in people with HIV-1, run by Janssen Scientific Affairs, LLC at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Body Weight at Week 24 (time frame: Baseline and Week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04442737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.