Status:
COMPLETED
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
Lead Sponsor:
Janssen Scientific Affairs, LLC
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04442737
Start Date
July 1 2020
End Date
August 30 2023
Last Update
March 30 2025
Active Locations (34)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35222
2
The Office of Franco Felizarta, MD
Bakersfield, California, United States, 93301
3
AIDS Health Foundation-Westside HCC
Beverly Hills, California, United States, 90211
4
Long Beach Education & Research Consultants
Long Beach, California, United States, 90813