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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

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ClinicalTrials.gov Identifier: NCT03227861
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

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.

Condition or disease Intervention/treatment Phase
HIV-1 Drug: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
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
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.




Primary Outcome Measures :
  1. Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Less Than (<) 50 Copies per Milliliter (Copies/mL) at Week 48 [ Time Frame: Week 48 ]
    Food and Drug Administration (FDA) Snapshot Approach is based on the last observed viral load data within the Week 48 window: virologic response is defined as HIV-1 RNA <50 copies/mL; missing HIV-1 RNA is considered as non-response.


Secondary Outcome Measures :
  1. Change From Baseline in log10 HIV-1 RNA Viral Load at Weeks 2, 4, 8, 12, 24, 36, and 48 [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48 ]
    The change from baseline in log 10 HIV-1 RNA viral load at weeks 2, 4, 8, 12, 24, 36, and 48 will be assessed.

  2. Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24 [ Time Frame: Week 24 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at week 24 will be assessed.

  3. Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24, and 48 [ Time Frame: Baseline, Weeks 12, 24, and 48 ]
    The immunologic change will be determined by changes in CD4+ cell count.

  4. Percentage of Participants Required Discontinuation After Enrollment Based on Safety Stopping Rules [ Time Frame: Day 10 ]
    Participants meeting any of the below safety stopping rules will be contacted to return to the study site for possible early study treatment discontinuation (ESTD): a) Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula <50 milliliter per minute (mL/min); b) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5* upper limit of normal (ULN); c) serum lipase >= 1.5* ULN; d) positive serum human chorionic gonadotropin pregnancy test (beta-hCG); e) laboratory results that the investigator believes should result in discontinuation of study medication and f) participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.

  5. Percentage of Participants Discontinuing Therapy due to Adverse Events (AEs) [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.

  6. Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0. [ Time Frame: Up to 30-day follow-up visit (maximum of 52 after enrollment) ]
    AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=potentially life-threatening) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.

  7. Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0. [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    Blood samples for serum chemistry and hematology and a urine sample for urinalysis will be collected at predefined time points for clinical laboratory testing. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.

  8. Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Drug due to Baseline Resistance Findings [ Time Frame: Up to Day 35 ]
    The percentage of participants meeting resistance stopping rules, requiring discontinuation of study drug due to baseline resistance findings will be reported. Resistance stopping Rule includes participants who do not show full sensitivity to all drugs in the FDC study regimen according to the susceptibility assessment in the GenoSure Prime report will be contacted to return to the study site for early study treatment discontinuation (ESTD). Exception for participants with identified resistance to lamivudine/ emtricitabine (FTC), attributed to the presence of the M184/V mutation alone will be permitted to remain in the study.

  9. Percentage of Participants With Baseline Protease (PR), Reverse Transcriptase (RT), and Integrase (INI) (Primary and Secondary) Resistance-Associated Mutation (RAMs) [ Time Frame: Baseline (Day 1) ]
    Percentage of participants with resistance-associated mutations present at baseline will be reported and include mutations in the domain of PR, RT, INI, RAMs as determined by the GenoSure Prime assay.

  10. Percentage of Participants Developing RAMs and Loss of Phenotypic Susceptibility, When Available, Upon Meeting Protocol-Defined Virologic Failure [ Time Frame: Up to Week 48 ]
    Participants who experience a protocol-defined virologic failure will be assessed for the development of RAMs and loss of phenotypic susceptibility. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12; b) virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or at any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.

  11. Percentage of Participants With Protocol-Defined Virologic Failure at Week 24 and Week 48 [ Time Frame: Week 24 and Week 48 ]
    Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.

  12. Percentage of Participants With Lost-to-Follow-up Throughout the 48 Weeks of Treatment [ Time Frame: Up to Week 48 ]
    The percentage of participants with lost-to-follow-up up to 48 weeks of treatment will be assessed.

  13. Percentage of Participants Discontinuing Study Drug for any Reason Other Than Withdrawal of Consent Prior to Week 48 who Have a Documented Clinic Visit With a Healthcare Provider Within 90 Days of Discontinuing Study Drug [ Time Frame: Up to Week 60 (Documented clinic visit within 90 Days of discontinuing study drug) ]
    The percentage of participants discontinuing study drug for any reason other than withdrawal of consent prior to week 48 who have a documented clinic visit with a healthcare provider within 90 days of discontinuing study drug will be reported.

  14. Adherence Rates by Pill Count at Weeks 4, 8, 12, 24, 36, and 48 [ Time Frame: Weeks 4, 8, 12, 24, 36, and 48 ]
    Adherence rates will be reported according to the percentage of participants taking >95%, 80-95% and <80% of study drug as assessed by pill count at study visits at Weeks 4, 12, 24, and 48. Participants will be requested to bring unused medication and empty packaging to the study site at each visit, and the amount of study drug dispensed will be compared with the amount returned, and taking into account the period elapsed since the previous visit to assess pill count.

  15. Adherence Rates by Participants Self-report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 [ Time Frame: Weeks 4, 8, 12, 24, 36, and 48 ]
    Treatment adherence based on participant self-report using a 4-day recall (that is self report over previous 4 days of treatment) will be summarized by means of descriptive statistics and frequency tabulations at Weeks 4, 8, 12, 24, 36, and 48.

  16. Mean Total Scores for the HIV Treatment Satisfaction Questionnaire-Status Version (HIVTSQs) at Weeks 4, 24, and 48 [ Time Frame: Weeks 4, 24, and 48 ]
    The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks.

  17. Number of Hospitalizations [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of hospitalizations with HIV-1 infected participants will be assessed up to 52 weeks.

  18. Duration of Hospitalizations [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The duration of hospitalizations for HIV-1 infected participants will be assessed up to 52 weeks.

  19. Number of Outpatient Visits [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of outpatient visits will be reported up to 52 week.

  20. Type of Outpatient Visits [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    Type of outpatient visits (example; general practitioner, specialist) will be reported up to 52 weeks.

  21. Number of Emergency Room Visits [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of emergency room visits will be reported up to 52 weeks.

  22. Number of Medications Used Throughout the Study [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of medications (including concomitant medication) used throughout the study will be reported.

  23. Type of Medications Used Throughout the Study [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The type of medications (including concomitant medication) used throughout the study will be reported.

  24. Direct Medical Costs [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The direct medical costs will be calculated up to 52 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227861


Locations
United States, Arizona
Spectrum Medical Group
Phoenix, Arizona, United States, 85012
United States, California
The Office of Franco Felizarta, MD
Bakersfield, California, United States, 93301
Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center
Los Angeles, California, United States, 90028
United States, District of Columbia
Whitman Walker Health
Washington, District of Columbia, United States, 20009
United States, Florida
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
University of Miami
Miami, Florida, United States, 33136
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Georgia
Chatham County Health Department
Savannah, Georgia, United States, 31401
United States, Illinois
The Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
United States, New Jersey
Saint Michael's Medical Center- Infectious Disease
Newark, New Jersey, United States, 07102
United States, New Mexico
Southwest CARE Center
Albuquerque, New Mexico, United States, 87109
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
United States, Texas
North Texas Infectious Diseases Consultants
Dallas, Texas, United States, 75246
Tarrant County Infectious Disease Associates
Fort Worth, Texas, United States, 76104
Therapeutic Concepts - Donald R Watkins Foundation
Houston, Texas, United States, 77004
Gordon Crofoot, MD
Houston, Texas, United States, 77098
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC

Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT03227861     History of Changes
Other Study ID Numbers: CR108345
TMC114FD2HTX3002 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Emtricitabine
Darunavir
Cobicistat
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors