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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)

Primary Purpose

HIV-1

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

D/C/F/TAF FDC

TAF/FTC FDC

INI Based Regimen

About this trial

This is an interventional treatment trial for HIV-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

D/C/F/TAF FDC Arm (Immediate Switch)

INI + TAF/FTC Arm (Delayed Switch)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Body Weight at Week 24

Percent change from baseline in body weight at Week 24 will be reported.

Secondary Outcome Measures

Change from Baseline in Absolute Body Weight at Weeks 24 and 48

Change from baseline in absolute body weight at Weeks 24 and 48 will be reported.

Percentage of Participants with Percent Change in Body Weight Greater Than (>) 3 Percent (%) at Weeks 24 and 48

Percentage of participants with % change in body weight >3% at Weeks 24 and 48 will be reported.

Percentage of Participants with Percent Change in Body Weight >5% at Weeks 24 and 48

Percentage of participants with % change in body weight >5% at Weeks 24 and 48 will be reported.

Change from Baseline in Body Mass Index (BMI) at Weeks 24 and 48

Change from baseline in BMI at Weeks 24 and 48 will be reported.

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 (absolute mass of fat, lean body mass and total mass) as measured by DEXA scan at Weeks 24 and 48 will be reported.

Change from Baseline in Waist Circumference at Weeks 24 and 48

Change from baseline in waist circumference at Weeks 24 and 48 will be reported.

Change from Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 24 and 48

Change from baseline in SBP and DBP from Baseline at Weeks 24 and 48 will be reported.

Change from Baseline in Fasting Lipids at Weeks 24 and 48

Change from baseline in fasting lipids at Weeks 24 and 48 will be reported. Fasting plasma lipids are measured to determine triglyceride or cholesterol concentrations.

Change from Baseline in Fasting Glucose at Weeks 24 and 48

Change from baseline in fasting glucose at Weeks 24 and 48 will be reported.

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 will be reported.

Change from Baseline in Hemoglobin A1c (HbA1c) at Weeks 24 and 48

Change from baseline in HbA1c at Weeks 24 and 48 will be reported.

Change from Baseline in Leptin at Weeks 24 and 48

Change from baseline in leptin at Weeks 24 and 48 will be reported.

Change from Baseline in Adiponectin at Weeks 24 and 48

Change from baseline in adiponectin at Weeks 24 and 48 will be reported.

Change from Baseline in the Percentage of Participants with Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48

Change from baseline in the percentage of participants with advanced fibrosis according to the NAFLD fibrosis score at Weeks 24 and 48 will be reported. In participants with NAFLD Score less than (< ) -1.455, advanced liver fibrosis can be excluded with high accuracy and NAFLD Score greater than (>) 0.675, the presence of advanced liver fibrosis can be diagnosed with high accuracy. Scores between -1.455 and 0.675 are considered "indeterminate".

Change from Baseline in the Percentage of Participants at High Risk of Nonalcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48

Change from baseline in the percentage of participants at high risk of NASH according to the HAIR score at Weeks 24 and 48 will be reported. HAIR score ranges from 0-3 which is calculated by adding Hypertension = 1, ALT >40 IU=1, and insulin resistance (IR) index >5.0 = 1. A score of greater than or equal to (>=) 2 is high risk for NASH.

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 from baseline to Weeks 24 and 48 will be reported.

Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agent

Percentage of participants initiating an anti-hypertensive, anti-hyperglycemic, or lipid lowering agent from baseline to Weeks 24 and 48 will be reported.

Percentage of Participants with any Grade Adverse Events (AEs)

Percentage of participants with any Grade AEs (related and not related) will be reported.

Percentage of Participants with Grade 3 and Grade 4 AEs

Percentage of participants with Grade 3 and Grade 4 AEs (related and not related) will be reported where Grade 3: Severe and Grade 4: Potentially life-threatening.

Percentage of Participants who Discontinued due to AEs

Percentage of participants who discontinued due to AEs will be reported.

Percentage of Participants with Serious Adverse Events (SAEs)

Percentage of participants with SAEs (related and not related) through Week 24 and Week 48 will be reported.

Change from Baseline in Biochemistry Tests

Change from baseline in biochemistry tests (such as sodium, potassium, chloride, bicarbonate, blood urea nitrogen, serum creatinine, glucose, aspartate aminotransferase, alanine aminotransferase, insulin, bilirubin [total, direct, indirect], alkaline phosphatase, calcium, calcium corrected for albumin, phosphate, albumin, total protein) through Weeks 24 and 48 will be reported.

Change from Baseline in Hematology Tests

Change from baseline in hematology tests (hematocrit, hemoglobin, platelet count, red blood cell count, absolute neutrophil count, white blood cell count) through Weeks 24 and 48 will be reported.

Change from Baseline in Urinalysis Tests

Change from baseline in urinalysis tests (specific gravity, pH, glucose, protein, blood ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase) through Weeks 24 and 48 will be reported.

Change from Baseline in Urine Chemistry Tests

If applicable, change from baseline in urine chemistry tests (urine creatinine, urine sodium, urine phosphate, urine glucose, urine albumin, urine protein, serum creatinine) through Weeks 24 and 48 will be reported.

Percentage of Participants with Grade 3 and Grade 4 Laboratory Abnormalities

Percentage of participants with Grade 3 and Grade 4 laboratory abnormalities will be reported.

Percentage of Participants with Confirmed Virologic Rebound

Percentage of participants with confirmed virologic rebound through Weeks 24 and 48 will be reported. Virologic rebound is defined as the 2 consecutive human immunodeficiency virus type-1 ribonucleic acid (HIV-1 RNA) values greater than or equal to (>=) 200 copies/milliliter (mL) at a scheduled or unscheduled visit after maintaining HIV-1 RNA less than (<) 50 copies/mL.

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 according to the Food Drug Administration (FDA) snapshot algorithm will be reported.

Percentage of Participants with Virologic Failure (HIV-1 RNA ≥50 copies/mL) at Weeks 24 and 48

Percentage participants with virologic failure (HIV-1 RNA >=50 copies/mL) at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.

Percentage of Participants Having Virologic Response (HIV-1 RNA<200 copies/mL) at Weeks 24 and 48

Percentage participants with virologic response (HIV-1 RNA < 200 copies/mL) at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.

Percentage of Participants Having Virologic Failure (HIV-1 RNA ≥200 copies/mL) at Weeks 24 and 48

Percentage participants having virologic failure, that is HIV-1 RNA >= 200 copies/mL, at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.

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 will be reported.

Percentage of Participants with Pre-baseline Protease (PR), Reverse Transcriptase (RT), and Integrase (INI) Resistance-Associated Mutation (RAMs)

Percentage of participants with pre-baseline PR, RT, and INI RAMs based on historical genotypes will be reported.

Percentage of Participant with Newly Identified Post-Baseline RAMS and Phenotypic Resistance Compared to Pre-baseline Resistance Tests

Percentage of participant with newly identified post-baseline RAMs and phenotypic resistance compared to pre-baseline resistance tests when available, upon meeting confirmed virologic rebound through Week 48.

Percentage of Participants with Genotypic and Phenotypic Antiretroviral (ARV) Resistance for Meeting HIV-1 RNA Rebound Criteria up to Weeks 24 and 48

Percentage of participants with genotypic and phenotypic ARV resistance who are meeting HIV-1 RNA rebound criteria through Weeks 24 and 48 will be reported.

Change from Baseline in the Percentage of Participants who Have Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across all Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48

Change from baseline in the percentage of participants who have bothersome symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 will be reported. The HIV-SI assesses 20 items which are evaluated on a scale of 0-4 where 0= I do not have this symptom to 4=It bothers me a lot'. Minimum HIV-SI score is 0 and maximum HIV-SI score is 80.

Change from Baseline in the Percentage of Participants who Have Any Symptoms (scores of 1, 2, 3 or 4) Across all Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48

Change from baseline in the percentage of participants who have any symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 will be reported.

Association Between Treatment Arm and Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Week 24

Association between treatment arm and each bothersome symptom of the HIV-SI adjusting for Baseline variables at Week 24 will be reported.

Patient Global Impression of Change (PGIC) Scale

The PGIC is a global index that is used to rate the overall status of the participant related to the participant's overall condition. It is rated by the participant and is based on the single question, "compared to before starting the study or compared to the Week 24 and Week 48 visits, my overall status is," where response choices include 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.

Adherence Rate to Treatment at Weeks 4, 12 and 24

Adherence rate to treatment will be assessed by participant self-report using 4-day recall at Weeks 4, 12, 24, 36 and 48.

Full Information

NCT ID

NCT04442737

First Posted

June 3, 2020

Last Updated

September 13, 2023

Sponsor

Janssen Scientific Affairs, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04442737

Brief Title

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

Acronym

DEFINE

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

July 1, 2020 (Actual)

Primary Completion Date

August 7, 2023 (Actual)

Study Completion Date

August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Scientific Affairs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

D/C/F/TAF FDC Arm (Immediate Switch)

Arm Type

Experimental

Arm Description

Arm Title

INI + TAF/FTC Arm (Delayed Switch)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

D/C/F/TAF FDC

Intervention Description

A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.

Intervention Type

Drug

Intervention Name(s)

TAF/FTC FDC

Intervention Description

TAF/FTC ARV regimen will be administered once daily.

Intervention Type

Drug

Intervention Name(s)

INI Based Regimen

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent Change from Baseline in Body Weight at Week 24

Description

Percent change from baseline in body weight at Week 24 will be reported.

Time Frame

Baseline and Week 24

Secondary Outcome Measure Information:

Title

Change from Baseline in Absolute Body Weight at Weeks 24 and 48

Description

Change from baseline in absolute body weight at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Percentage of Participants with Percent Change in Body Weight Greater Than (>) 3 Percent (%) at Weeks 24 and 48

Description

Percentage of participants with % change in body weight >3% at Weeks 24 and 48 will be reported.

Time Frame

Weeks 24 and 48

Title

Percentage of Participants with Percent Change in Body Weight >5% at Weeks 24 and 48

Description

Percentage of participants with % change in body weight >5% at Weeks 24 and 48 will be reported.

Time Frame

Weeks 24 and 48

Title

Change from Baseline in Body Mass Index (BMI) at Weeks 24 and 48

Description

Change from baseline in BMI at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Body Composition as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan at Weeks 24 and 48

Description

Change from baseline in body composition (absolute mass of fat, lean body mass and total mass) as measured by DEXA scan at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Waist Circumference at Weeks 24 and 48

Description

Change from baseline in waist circumference at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 24 and 48

Description

Change from baseline in SBP and DBP from Baseline at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Fasting Lipids at Weeks 24 and 48

Description

Change from baseline in fasting lipids at Weeks 24 and 48 will be reported. Fasting plasma lipids are measured to determine triglyceride or cholesterol concentrations.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Fasting Glucose at Weeks 24 and 48

Description

Change from baseline in fasting glucose at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Weeks 24 and 48

Description

Change from baseline in HOMA-IR at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Hemoglobin A1c (HbA1c) at Weeks 24 and 48

Description

Change from baseline in HbA1c at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Leptin at Weeks 24 and 48

Description

Change from baseline in leptin at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Adiponectin at Weeks 24 and 48

Description

Change from baseline in adiponectin at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in the Percentage of Participants with Advanced Fibrosis as Assessed by Non-alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score at Weeks 24 and 48

Description

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in the Percentage of Participants at High Risk of Nonalcoholic Fatty Liver Disease (NASH) According to the Hypertension, Age, Insulin, Resistance (HAIR) Score at Weeks 24 and 48

Description

Time Frame

Baseline, Weeks 24 and 48

Title

Percentage of Participants with a Dose-reduction or Complete Withdrawal of Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agents

Description

Percentage of participants with a dose-reduction or complete withdrawal of anti-hypertensive, anti-hyperglycemic, or lipid lowering agents from baseline to Weeks 24 and 48 will be reported.

Time Frame

Baseline up to Weeks 24 and 48

Title

Percentage of Participants Initiating an Anti-hypertensive, Anti-hyperglycemic, or Lipid Lowering Agent

Description

Percentage of participants initiating an anti-hypertensive, anti-hyperglycemic, or lipid lowering agent from baseline to Weeks 24 and 48 will be reported.

Time Frame

Baseline up to Weeks 24 and 48

Title

Percentage of Participants with any Grade Adverse Events (AEs)

Description

Percentage of participants with any Grade AEs (related and not related) will be reported.

Time Frame

Up to 24 and 48 weeks

Title

Percentage of Participants with Grade 3 and Grade 4 AEs

Description

Percentage of participants with Grade 3 and Grade 4 AEs (related and not related) will be reported where Grade 3: Severe and Grade 4: Potentially life-threatening.

Time Frame

Up to 24 and 48 weeks

Title

Percentage of Participants who Discontinued due to AEs

Description

Percentage of participants who discontinued due to AEs will be reported.

Time Frame

Up to 24 and 48 weeks

Title

Percentage of Participants with Serious Adverse Events (SAEs)

Description

Percentage of participants with SAEs (related and not related) through Week 24 and Week 48 will be reported.

Time Frame

Up to 24 and 48 weeks

Title

Change from Baseline in Biochemistry Tests

Description

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Hematology Tests

Description

Change from baseline in hematology tests (hematocrit, hemoglobin, platelet count, red blood cell count, absolute neutrophil count, white blood cell count) through Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Urinalysis Tests

Description

Change from baseline in urinalysis tests (specific gravity, pH, glucose, protein, blood ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase) through Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in Urine Chemistry Tests

Description

Time Frame

Baseline, Weeks 24 and 48

Title

Percentage of Participants with Grade 3 and Grade 4 Laboratory Abnormalities

Description

Percentage of participants with Grade 3 and Grade 4 laboratory abnormalities will be reported.

Time Frame

Up to 24 and 48 weeks

Title

Percentage of Participants with Confirmed Virologic Rebound

Description

Time Frame

Up to Weeks 24 and 48

Title

Percentage of Participants with Virologic Response (HIV-1 RNA<50 copies/mL) at Weeks 24 and 48

Description

Percentage of participants with virologic response (HIV-1 RNA <50 copies/mL), at Weeks 24 and 48 according to the Food Drug Administration (FDA) snapshot algorithm will be reported.

Time Frame

Weeks 24 and 48

Title

Percentage of Participants with Virologic Failure (HIV-1 RNA ≥50 copies/mL) at Weeks 24 and 48

Description

Percentage participants with virologic failure (HIV-1 RNA >=50 copies/mL) at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.

Time Frame

Weeks 24 and 48

Title

Percentage of Participants Having Virologic Response (HIV-1 RNA<200 copies/mL) at Weeks 24 and 48

Description

Percentage participants with virologic response (HIV-1 RNA < 200 copies/mL) at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.

Time Frame

Weeks 24 and 48

Title

Percentage of Participants Having Virologic Failure (HIV-1 RNA ≥200 copies/mL) at Weeks 24 and 48

Description

Percentage participants having virologic failure, that is HIV-1 RNA >= 200 copies/mL, at Weeks 24 and 48 according to the FDA snapshot algorithm will be reported.

Time Frame

Weeks 24 and 48

Title

Change from Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Weeks 24 and 48

Description

Change from baseline in CD4+ cell count at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Percentage of Participants with Pre-baseline Protease (PR), Reverse Transcriptase (RT), and Integrase (INI) Resistance-Associated Mutation (RAMs)

Description

Percentage of participants with pre-baseline PR, RT, and INI RAMs based on historical genotypes will be reported.

Time Frame

Baseline (Day 1)

Title

Percentage of Participant with Newly Identified Post-Baseline RAMS and Phenotypic Resistance Compared to Pre-baseline Resistance Tests

Description

Time Frame

Up to Week 48

Title

Percentage of Participants with Genotypic and Phenotypic Antiretroviral (ARV) Resistance for Meeting HIV-1 RNA Rebound Criteria up to Weeks 24 and 48

Description

Percentage of participants with genotypic and phenotypic ARV resistance who are meeting HIV-1 RNA rebound criteria through Weeks 24 and 48 will be reported.

Time Frame

Up to Weeks 24 and 48

Title

Change from Baseline in the Percentage of Participants who Have Bothersome Symptoms (Scores of 1, 2, 3 or 4) Across all Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48

Description

Time Frame

Baseline, Weeks 24 and 48

Title

Change from Baseline in the Percentage of Participants who Have Any Symptoms (scores of 1, 2, 3 or 4) Across all Items of the HIV-Symptom Index (HIV-SI) at Weeks 24 and 48

Description

Change from baseline in the percentage of participants who have any symptoms (scores of 1, 2, 3 or 4) across all items of the HIV-SI at Weeks 24 and 48 will be reported.

Time Frame

Baseline, Weeks 24 and 48

Title

Association Between Treatment Arm and Each Bothersome Symptom of the HIV-SI Adjusting for Baseline Variables at Week 24

Description

Association between treatment arm and each bothersome symptom of the HIV-SI adjusting for Baseline variables at Week 24 will be reported.

Time Frame

Week 24

Title

Patient Global Impression of Change (PGIC) Scale

Description

Time Frame

Weeks 24 and 48

Title

Adherence Rate to Treatment at Weeks 4, 12 and 24

Description

Adherence rate to treatment will be assessed by participant self-report using 4-day recall at Weeks 4, 12, 24, 36 and 48.

Time Frame

Weeks 4, 12, 24, 36 and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Scientific Affairs, LLC Clinical Trial

Organizational Affiliation

Janssen Scientific Affairs, LLC

Official's Role

Study Director

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35222

Country

United States

Facility Name

The Office of Franco Felizarta, MD

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

AIDS Health Foundation-Westside HCC

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Long Beach Education & Research Consultants

City

Long Beach

State/Province

California

ZIP/Postal Code

90813

Country

United States

Facility Name

Midway Immunology and Research Center

City

Fort Pierce

State/Province

Florida

ZIP/Postal Code

34982

Country

United States

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Triple O Research Institute

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Atlanta ID Group

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

Medical College of Georgia

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

The Corporation of Mercer University

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Chatham County Health Department

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31401

Country

United States

Facility Name

The Ruth M. Rothstein CORE Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Care South Clinic

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70806

Country

United States

Facility Name

Kaiser Permanente

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Community Research Initiative

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02129

Country

United States

Facility Name

Be Well Medical Center, PC

City

Berkley

State/Province

Michigan

ZIP/Postal Code

48072

Country

United States

Facility Name

Henry Ford Health System

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

University of Nebraska

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68106

Country

United States

Facility Name

Saint Michaels Medical Center - Infectious Disease

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

AIDS Healthcare Foundation-Research Center

City

New York

State/Province

New York

ZIP/Postal Code

10001

Country

United States

Facility Name

Mount Sinai Hospital-New York

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Philadelphia Fight

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Palmetto Health - USC

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29203

Country

United States

Facility Name

AIDS Arms Incorporated Trinity Health and Wellness Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75208

Country

United States

Facility Name

North Texas Infectious Diseases Consultants

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Texas Centers for Infectious Disease Associates

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Therapeutic Concepts - Donald R Watkins Foundation

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

DCOL Center for Clinical Research

City

Longview

State/Province

Texas

ZIP/Postal Code

75605

Country

United States

Facility Name

Infectious Disease Associates of Central Virginia

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

Facility Name

Vivent Health

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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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)

HIV-1

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial