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

• Status: Recruiting
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC

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 12-to-36-month 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