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

ID#: NCT04442737

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 4

Recruitment Status: Recruiting

Start Date: July 01, 2020

End Date: March 10, 2022

Contact Information:
Study Contact
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.

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