Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 06 September 2018

The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus...

purpose

Brief Summary:
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 109 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed-dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Receiving Care in a Test and Treat Model of Care
Actual Study Start Date: July 31, 2017
Estimated Primary Completion Date: December 31, 2018
Estimated Study Completion Date: December 31, 2018

Arm:
- Experimental:
DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC

Category Value
Date last updated at source 30-May-18
Study type(s) Interventional
Expected enrolment 109
Study start date 31-Jul-17
Estimated primary completion date 31-Dec-18

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