Clinical trial NCT03227861: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2017-07-24
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
timeFrame: Week 48
Secondary outcomes:
measure: Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48
measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
timeFrame: Week 24
measure: Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48
timeFrame: Baseline, Weeks 12, 24 and 48
measure: Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules
timeFrame: Up to Week 48
measure: Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)
timeFrame: Up to Week 48
measure: Percentage of Participants Experiencing Grade 3 and 4 Adverse Events
timeFrame: Up to Week 48
measure: Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities
timeFrame: Up to Week 48
measure: Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings
timeFrame: Up to Day 35
measure: Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)
timeFrame: Baseline (Day 1)
measure: Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48
timeFrame: Week 24 and 48
measure: Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)
timeFrame: Up to Week 48
measure: Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment
timeFrame: Up to Week 48
measure: Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit
timeFrame: Up to Week 48
measure: Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48
timeFrame: Weeks 4, 8, 12, 24, 36, and 48
measure: Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48
timeFrame: Weeks 4, 8, 12, 24, 36, and 48
measure: Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48
timeFrame: Weeks 4, 24, and 48
measure: Number of Participants With Hospitalizations
timeFrame: Up to Week 48
measure: Duration of Hospitalizations
timeFrame: Up to Week 48
measure: Number of Participants With Outpatient Visits
timeFrame: Up to Week 48
measure: Number of Participants With Emergency Room Visits
timeFrame: Up to Week 48
measure: Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])
timeFrame: Up to Week 48
measure: Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96
timeFrame: Up to Week 96
measure: Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96
timeFrame: Up to Week 96
measure: Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96
timeFrame: Up to Week 96
measure: Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96
timeFrame: Weeks 72 and 96
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Spectrum Medical Group
state: Arizona
city: Bakersfield
country: United States
facility: The Office of Franco Felizarta, MD
state: California
city: Los Angeles
country: United States
facility: Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center
state: California
city: Washington
country: United States
facility: Whitman Walker Health
state: District of Columbia
city: Fort Pierce
country: United States
facility: Midway Immunology and Research Center
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Savannah
country: United States
facility: Chatham County Health Department
state: Georgia
city: Chicago
country: United States
facility: The Ruth M. Rothstein CORE Center
state: Illinois
city: Newark
country: United States
facility: Saint Michaels Medical Center - Infectious Disease
state: New Jersey
city: Albuquerque
country: United States
facility: Southwest CARE Center
state: New Mexico
city: Santa Fe
country: United States
facility: Southwest CARE Center
state: New Mexico
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants
state: Texas
city: Fort Worth
country: United States
facility: Texas Centers for Infectious Disease Associates
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts - Donald R Watkins Foundation
state: Texas
city: Houston
country: United States
facility: Gordon Crofoot, MD
state: Texas
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Dunn K, Rogers R, Simonson RB, Luo D, Sheng S, Kassam PT, Seyedkazemi S, Hardy H. Rapid initiation of darunavir/cobicistat/emtricitabine/tenofovir alafenamide in acute and early HIV-1 infection: a DIAMOND subgroup analysis. HIV Res Clin Pract. 2021 Apr;22(2):55-61. doi: 10.1080/25787489.2021.1915652. Epub 2021 May 17.
citation: Huhn GD, Crofoot G, Ramgopal M, Gathe J, Bolan R, Luo D, Simonson RB, Nettles RE, Benson C, Dunn K. Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in a Rapid-Initiation Model of Care for Human Immunodeficiency Virus Type 1 Infection: Primary Analysis of the DIAMOND Study. Clin Infect Dis. 2020 Dec 15;71(12):3110-3117. doi: 10.1093/cid/ciz1213.