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 (DEFINE)

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.

Study Overview

• Status: Completed
• Conditions: HIV-1
• Intervention / Treatment: Drug: D/C/F/TAF FDC; Drug: TAF/FTC FDC; Drug: INI Based Regimen

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35222
      • University of Alabama at Birmingham
  • California
    • Bakersfield, California, United States, 93301
      • The Office of Franco Felizarta, MD
    • Beverly Hills, California, United States, 90211
      • AIDS Health Foundation-Westside HCC
    • Long Beach, California, United States, 90813
      • Long Beach Education & Research Consultants
  • Florida
    • Fort Pierce, Florida, United States, 34982
      • Midway Immunology and Research Center
    • Miami, Florida, United States, 33136
      • University of Miami
    • West Palm Beach, Florida, United States, 33407
      • Triple O Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Atlanta ID Group
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia
    • Macon, Georgia, United States, 31201
      • The Corporation of Mercer University
    • Savannah, Georgia, United States, 31401
      • Chatham County Health Department
  • Illinois
    • Chicago, Illinois, United States, 60612
      • The Ruth M. Rothstein CORE Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Care South Clinic
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Kaiser Permanente
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Community Research Initiative
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Be Well Medical Center, PC
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • University of Nebraska
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Saint Michaels Medical Center - Infectious Disease
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10001
      • AIDS Healthcare Foundation-Research Center
    • New York, New York, United States, 10029
      • Mount Sinai Hospital-New York
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia FIGHT
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health - USC
  • Texas
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants
    • Dallas, Texas, United States, 75208
      • AIDS Arms Incorporated Trinity Health and Wellness Center
    • Fort Worth, Texas, United States, 76104
      • Texas Centers for Infectious Disease Associates
    • Houston, Texas, United States, 77004
      • Therapeutic Concepts - Donald R Watkins Foundation
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Infectious Disease Associates of Central Virginia
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53203
      • Vivent Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: 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.; Drug: TAF/FTC FDC; TAF/FTC ARV regimen will be administered once daily.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Body Weight at Week 24	Percent change from baseline in body weight at Week 24 were reported.	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.	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.	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.	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.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Absolute Body Weight Over Time	Change from baseline in absolute body weight over time were reported.	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.	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.	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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".	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.	Weeks 4, 12, 24, 36 and 48

Collaborators and Investigators

• Sponsor: Janssen Scientific Affairs, LLC
• Investigators: Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: CR108757; TMC114FD2HTX4004 (Other Identifier: Janssen Scientific Affairs, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No