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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

Primary Purpose

HIV-1

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Sponsored by
Janssen Scientific Affairs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spectrum Medical Group
  • The Office of Franco Felizarta, MD
  • Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center
  • Whitman Walker Health
  • Midway Immunology and Research Center
  • University of Miami
  • Orlando Immunology Center
  • Chatham County Health Department
  • The Ruth M. Rothstein CORE Center
  • Saint Michael's Medical Center - Infectious Disease
  • Southwest CARE Center
  • Southwest CARE Center
  • North Texas Infectious Diseases Consultants
  • Texas Centers for Infectious Disease Associates
  • Therapeutic Concepts - Donald R Watkins Foundation
  • Gordon Crofoot, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48
Change from baseline in log10 HIV-1 RNA viral load (<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
Percentage of participants with HIV-1 RNA < 50 copies/mL were reported.
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.
Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules
Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: 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) greater than or equal to (>=) 2.5*upper limit of normal (ULN); c). Serum lipase >=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; 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.
Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events
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=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings
Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.
Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)
Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [<500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility).
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 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.
Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)
Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. 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.
Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment
Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.
Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit
Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.
Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48
Percentage of participants with treatment adherence >95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (>) 95 percent (%) by pill count.
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
Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.
Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48
The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. 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). The higher the score, the greater the treatment satisfaction.
Number of Participants With Hospitalizations
Number of participants with hospitalizations (overnight) was reported.
Duration of Hospitalizations
Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.
Number of Participants With Outpatient Visits
Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.
Number of Participants With Emergency Room Visits
Number of participants with emergency room visits was reported.
Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])
Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.
Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96
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=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 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.

Full Information

First Posted
July 21, 2017
Last Updated
September 2, 2020
Sponsor
Janssen Scientific Affairs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03227861
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
January 3, 2019 (Actual)
Study Completion Date
September 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Scientific Affairs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Intervention Description
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 Measure Information:
Title
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
Description
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.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48
Description
Change from baseline in log10 HIV-1 RNA viral load (<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48
Title
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
Description
Percentage of participants with HIV-1 RNA < 50 copies/mL were reported.
Time Frame
Week 24
Title
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48
Description
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.
Time Frame
Baseline, Weeks 12, 24 and 48
Title
Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules
Description
Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: 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) greater than or equal to (>=) 2.5*upper limit of normal (ULN); c). Serum lipase >=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; 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.
Time Frame
Up to Week 48
Title
Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)
Description
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame
Up to Week 48
Title
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events
Description
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=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Time Frame
Up to Week 48
Title
Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities
Description
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
Time Frame
Up to Week 48
Title
Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings
Description
Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.
Time Frame
Up to Day 35
Title
Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)
Description
Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [<500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility).
Time Frame
Baseline (Day 1)
Title
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48
Description
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 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.
Time Frame
Week 24 and 48
Title
Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)
Description
Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. 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.
Time Frame
Up to Week 48
Title
Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment
Description
Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.
Time Frame
Up to Week 48
Title
Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit
Description
Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.
Time Frame
Up to Week 48
Title
Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48
Description
Percentage of participants with treatment adherence >95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (>) 95 percent (%) by pill count.
Time Frame
Weeks 4, 8, 12, 24, 36, and 48
Title
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
Description
Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.
Time Frame
Weeks 4, 8, 12, 24, 36, and 48
Title
Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48
Description
The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. 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). The higher the score, the greater the treatment satisfaction.
Time Frame
Weeks 4, 24, and 48
Title
Number of Participants With Hospitalizations
Description
Number of participants with hospitalizations (overnight) was reported.
Time Frame
Up to Week 48
Title
Duration of Hospitalizations
Description
Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.
Time Frame
Up to Week 48
Title
Number of Participants With Outpatient Visits
Description
Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.
Time Frame
Up to Week 48
Title
Number of Participants With Emergency Room Visits
Description
Number of participants with emergency room visits was reported.
Time Frame
Up to Week 48
Title
Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])
Description
Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.
Time Frame
Up to Week 48
Title
Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96
Description
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time Frame
Up to Week 96
Title
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96
Description
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=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Time Frame
Up to Week 96
Title
Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96
Description
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
Time Frame
Up to Week 96
Title
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96
Description
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 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.
Time Frame
Weeks 72 and 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Scientific Affairs, LLC Clinical Trial
Organizational Affiliation
Janssen Scientific Affairs, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Spectrum Medical Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
The Office of Franco Felizarta, MD
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
Whitman Walker Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Midway Immunology and Research Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Chatham County Health Department
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31401
Country
United States
Facility Name
The Ruth M. Rothstein CORE Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Saint Michael's Medical Center - Infectious Disease
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Southwest CARE Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Southwest CARE Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
North Texas Infectious Diseases Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Centers for Infectious Disease Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Therapeutic Concepts - Donald R Watkins Foundation
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Gordon Crofoot, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33999786
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.
Results Reference
derived
PubMed Identifier
31879782
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.
Results Reference
derived

Learn more about this trial

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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