A Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed Dose Combination (FDC) Versus a Regimen Consisting of Darunavir/Cobicistat FDC With Emtricitabine/Tenofovir Disoproxil Fumarate FDC in Treatment-naive HIV Type 1 Infected Subjects



Status:Active, not recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:July 6, 2015
End Date:December 31, 2019

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A Phase 3, Randomized, Active-controlled, Double-blind Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 Infected Subjects

The purpose of this study is to demonstrate non-inferiority in efficacy of a
darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination
(FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with
Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1
(HIV-1) infected, antiretroviral (ARV) treatment naive adult participants.

This is a Phase 3, multicenter (when more than one hospital or medical school team work on a
medical research study), randomized (study drug assigned by chance), double-blind (a medical
research study in which neither the researchers nor the participant know what treatment the
participant is receiving), active-controlled (study in which the experimental treatment or
procedure is compared to a standard [control] treatment or procedure) study. The study
consists of 5 periods: a Screening period, Double-blind treatment period, Single-arm
treatment period, Extension period and a Follow-up period. Participants will receive either
darunavir (DRV)/ cobicistat (COBI)/emtricitabine (FTC) /tenofovir alafenamide (TAF) fixed
dose combination (D/C/F/TAF FDC) or DRV/COBI FDC along with FTC/TDF FDC. Primarily percentage
of participants with human immunodeficiency virus (HIV) -1 Ribonucleic acid (RNA) less than
(<) 50 copies per milliliter (copies/ml) defined by snapshot analysis will be evaluated.
Participants' safety will be monitored throughout the study.

Inclusion Criteria:

- Subject must be antiretroviral (ARV) treatment-naive (never treated with an ARV
including post-exposure prophylaxis and pre-exposure prophylaxis); no prior use of any
approved or experimental anti- human immunodeficiency virus (anti-HIV) drug for any
length of time

- Screening plasma HIV-1 ribonucleic acid (RNA) level greater than or equal to >=1,000
copies per milliliter (copies/mL)

- Cluster of Differentiation 4+ (CD4+) cell count >50 cells/microliter (cells/mcL)

- Screening HIV-1 genotype report must show full sensitivity to DRV, TDF and FTC

- Screening eGFRcreatinine >=70 mL/min according to the Cockcroft-Gault formula for
creatinine clearance

Exclusion Criteria:

- Subject has been diagnosed with a new acquired immunodeficiency syndrome
(AIDS)-defining condition within the 30 days prior to screening

- Subject has proven or suspected acute hepatitis within 30 days prior to screening

- Subject is hepatitis C or hepatitis B positive

- Subject has a history of cirrhosis
We found this trial at
31
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Springfield, Massachusetts 01199
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