Status:
COMPLETED
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
Lead Sponsor:
Janssen Scientific Affairs, LLC
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2019
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03227861
Start Date
July 31 2017
End Date
September 4 2019
Last Update
February 4 2025
Active Locations (16)
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1
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
2
The Office of Franco Felizarta, MD
Bakersfield, California, United States, 93301
3
Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center
Los Angeles, California, United States, 90028
4
Whitman Walker Health
Washington D.C., District of Columbia, United States, 20009