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

ClinicalTrials.gov ID: NCT03227861

Public ClinicalTrials.gov record NCT03227861. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 6, 2026, 2:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID: NCT03227861
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Janssen Scientific Affairs, LLC; Industry
Enrollment: 109 participants

Conditions and interventions

Conditions

HIV-1

Interventions

DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 30, 2017
Primary completion: Jan 2, 2019
Completion: Sep 3, 2019
Last update posted: Feb 3, 2025

2017 – 2019

United States locations

U.S. sites: 16
U.S. states: 9
U.S. cities: 15

Facility	City	State	ZIP	Site status
Spectrum Medical Group	Phoenix	Arizona	85012	—
The Office of Franco Felizarta, MD	Bakersfield	California	93301	—
Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center	Los Angeles	California	90028	—
Whitman Walker Health	Washington D.C.	District of Columbia	20009	—
Midway Immunology and Research Center	Ft. Pierce	Florida	34982	—
University of Miami	Miami	Florida	33136	—
Orlando Immunology Center	Orlando	Florida	32803	—
Chatham County Health Department	Savannah	Georgia	31401	—
The Ruth M. Rothstein CORE Center	Chicago	Illinois	60612	—
Saint Michaels Medical Center - Infectious Disease	Newark	New Jersey	07102	—
Southwest CARE Center	Albuquerque	New Mexico	87109	—
Southwest CARE Center	Santa Fe	New Mexico	87505	—
North Texas Infectious Diseases Consultants	Dallas	Texas	75246	—
Texas Centers for Infectious Disease Associates	Fort Worth	Texas	76104	—
Therapeutic Concepts - Donald R Watkins Foundation	Houston	Texas	77004	—
Gordon Crofoot, MD	Houston	Texas	77098	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03227861, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 3, 2025 · Synced May 6, 2026

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The complete protocol, eligibility criteria, and contact information for NCT03227861 live on ClinicalTrials.gov.

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