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 and Treat Model of Care



Status:Active, not recruiting
Conditions:HIV / AIDS, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:July 31, 2017
End Date:July 31, 2019

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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

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.


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
We found this trial at
16
sites
1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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4710 Jefferson Street Northeast
Albuquerque, New Mexico 87109
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3535 San Dimas Street
Bakersfield, California 93301
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Chicago, Illinois 60612
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Dallas, TX
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Fort Pierce, Florida 34982
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Fort Worth, TX
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Houston, Texas 77098
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111 Central Avenue
Newark, New Jersey 07102
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Phoenix, Arizona 85012
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Santa Fe, New Mexico 87505
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Savannah, Georgia 31406
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Washington, District of Columbia 20009
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