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

NCT03227861 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CR108345TMC114FD2HTX3002
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 16

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.

Conditions

HIV-1

Outcome Measures

Primary Outcomes (1)

• 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

  Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is \< 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.

  Week 48

Secondary Outcomes (25)

• Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48

  Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48

• Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24

  Week 24

• Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48

  Baseline, Weeks 12, 24 and 48

• Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules

  Up to Week 48

• Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)

  Up to Week 48

Study Arms (1)

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

EXPERIMENTAL

Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit.

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

Interventions

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

Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Scientific Affairs, LLC: lead

Study Sites (16)

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

The Office of Franco Felizarta, MD

Bakersfield, California, 93301, United States

Location

Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center

Los Angeles, California, 90028, United States

Location

Whitman Walker Health

Washington D.C., District of Columbia, 20009, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Chatham County Health Department

Savannah, Georgia, 31401, United States

Location

The Ruth M. Rothstein CORE Center

Chicago, Illinois, 60612, United States

Location

Saint Michaels Medical Center - Infectious Disease

Newark, New Jersey, 07102, United States

Location

Southwest CARE Center

Albuquerque, New Mexico, 87109, United States

Location

Southwest CARE Center

Santa Fe, New Mexico, 87505, United States

Location

North Texas Infectious Diseases Consultants

Dallas, Texas, 75246, United States

Location

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

Therapeutic Concepts - Donald R Watkins Foundation

Houston, Texas, 77004, United States

Location

Gordon Crofoot, MD

Houston, Texas, 77098, United States

Location

Related Publications (2)

• 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.

  PMID: 33999786 DERIVED

• 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.

  PMID: 31879782 DERIVED

MeSH Terms

Interventions

Racivir

Limitations and Caveats

Study limitations included the open-label, single-arm study design and the small sample size.

Results Point of Contact

• Title: Senior director medical leader
• Organization: Janssen Scientific Affairs, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Scientific Affairs, LLC Clinical Trial

  Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 24, 2017
• Study Start: July 31, 2017
• Primary Completion: January 3, 2019
• Study Completion: September 4, 2019
• Last Updated: February 4, 2025
• Results First Posted: January 7, 2020

Record last verified: 2025-01

Locations

US (16)