Overview

A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test

Status:
Completed
Trial end date:
2019-09-04
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Scientific Affairs, LLC
Treatments:
Cobicistat
Darunavir
Emtricitabine
Criteria
Inclusion Criteria:

- Newly diagnosed with human immunodeficiency virus type 1 (HIV-1) evidenced by any of
the following within 2 weeks of the screening/baseline visit: a) HIV Rapid Antibody
positive; or b) HIV Immunoassay positive; or c) Positive p24 antigen and a HIV-1
ribonucleic acid (RNA) viral load greater than or equal to (>=) 5,000 copies per
milliliter (copies/ mL); or d) Non-reactive HIV-1 antibody/antigen assays and HIV-1
RNA viral load (>=) 5,000 copies/mL. HIV-1 RNA viral load must be confirmed once
within 1 week of initial HIV-1 RNA viral load test

- Antiretroviral treatment-naïve, except for the use of TRUVADA® for pre-exposure
prophylaxis (PrEP)

- Must be able to swallow whole tablets

- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during the study and for 90 days after receiving the last dose of study
drug

- A woman of childbearing potential must have a negative urine pregnancy test at
screening

Exclusion Criteria:

- Known active cryptococcal infection, active toxoplasmic encephalitis, Mycobacterium
tuberculosis infection, or another acquired immunodeficiency syndrome (AIDS) -defining
condition that in the judgement of the investigator would increase the risk of
morbidity or mortality

- Known history of clinically relevant hepatic disease or hepatitis that in the
investigator's judgement is not compatible with Darunavir/ Cobicistat/ Emtricitabine/
Tenofovir Alafenamide (D/C/F/TAF FDC)

- Known history of cirrhosis as diagnosed based on local practices

- Known history of chronic ([>=] 3 months) renal insufficiency, defined as having an
estimated glomerular filtration rate (eGFR) less than (<) 50 milliliter per minute
(mL/min) according to the Modification of Diet in Renal Disease (MDRD) formula

- Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this
study or within 90 days after the last dose of study treatment