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D/C/F/TAF FDC Evaluated as a Fixed Dose Combination Regimen in Participants Switching from an Integrase Inhibitor who have Experienced Rapid Weight Gain
Overall Recruitment Status: Active, currently enrolling
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
Region Sponsors
Janssen Scientific Affairs, LLC
Acronym KP IRB No.
DEFINE 1688046
Study Type Phase
Clinical Trial Phase IV
Study Population Description
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.
Detailed Description
Gender Age Limit
Male & Female
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 12 months' time period 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

Keywords and/or Specific Medical Conditions
  • Infectious Diseases
KP Clinical Facility
  • Largo Medical Center
Clinical Area
  • Infectious Diseases

Principal Investigator:
Michael Horberg, MD
Contact Information:
- Charmaine McKie, MPH, PhD, RN
-Largo Medical Center
- Leslie Greenberg, MS, RN
-Largo Medical Center
- Peter Kadlecik, MD
-301 618 5647
-Burke Medical Center

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