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
Savannah, Georgia 31406
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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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Miami, FL
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4710 Jefferson Street Northeast
Albuquerque, New Mexico 87109
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Albuquerque, NM
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3535 San Dimas Street
Bakersfield, California 93301
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Bakersfield, CA
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Chicago, Illinois 60612
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Chicago, IL
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Dallas, TX
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Fort Pierce, Florida 34982
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Fort Pierce, FL
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Fort Worth, TX
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Houston, TX
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Houston, Texas 77098
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Houston, TX
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Los Angeles, CA
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111 Central Avenue
Newark, New Jersey 07102
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Newark, NJ
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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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Orlando, FL
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Phoenix, Arizona 85012
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Phoenix, AZ
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Santa Fe, New Mexico 87505
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Santa Fe, NM
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Washington, District of Columbia 20009
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Washington,
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