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

Completed · Phase 4

Conditions studied: HIV-1

In brief

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.

Key facts

Study ID

NCT04442737

Run by

Janssen Scientific Affairs, LLC

People needed

103

Starts

2020-07-01

Expected to finish

2023-08-30

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• The Office of Franco Felizarta, MD — Bakersfield, California, United States
• AIDS Health Foundation-Westside HCC — Beverly Hills, California, United States
• Long Beach Education & Research Consultants — Long Beach, California, United States
• Midway Immunology and Research Center — Ft. Pierce, Florida, United States
• University of Miami — Miami, Florida, United States
• Triple O Research Institute — West Palm Beach, Florida, United States
• Atlanta ID Group — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• The Corporation of Mercer University — Macon, Georgia, United States
• Chatham County Health Department — Savannah, Georgia, United States
• The Ruth M. Rothstein CORE Center — Chicago, Illinois, United States
• Care South Clinic — Baton Rouge, Louisiana, United States
• Kaiser Permanente — Rockville, Maryland, United States
• Community Research Initiative — Boston, Massachusetts, United States
• Be Well Medical Center, PC — Berkley, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Saint Michaels Medical Center - Infectious Disease — Newark, New Jersey, United States
• AIDS Healthcare Foundation-Research Center — New York, New York, United States
• Mount Sinai Hospital-New York — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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