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
Completed · Phase 3
Conditions studied: HIV-1
In brief
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.
Key facts
- Study ID
- NCT03227861
- Run by
- Janssen Scientific Affairs, LLC
- People needed
- 109
- Starts
- 2017-07-31
- Expected to finish
- 2019-09-04
- Last updated by the study team
- 2025-02-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Spectrum Medical Group — Phoenix, Arizona, United States
- The Office of Franco Felizarta, MD — Bakersfield, California, United States
- Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center — Los Angeles, California, United States
- Whitman Walker Health — Washington D.C., District of Columbia, United States
- Midway Immunology and Research Center — Ft. Pierce, Florida, United States
- University of Miami — Miami, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- Chatham County Health Department — Savannah, Georgia, United States
- The Ruth M. Rothstein CORE Center — Chicago, Illinois, United States
- Saint Michaels Medical Center - Infectious Disease — Newark, New Jersey, United States
- Southwest CARE Center — Albuquerque, New Mexico, United States
- Southwest CARE Center — Santa Fe, New Mexico, United States
- North Texas Infectious Diseases Consultants — Dallas, Texas, United States
- Texas Centers for Infectious Disease Associates — Fort Worth, Texas, United States
- Therapeutic Concepts - Donald R Watkins Foundation — Houston, Texas, United States
- Gordon Crofoot, MD — Houston, Texas, United States
Full record on ClinicalTrials.gov
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