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| ID | Type | Description | Link |
|---|---|---|---|
| TMC114FD2HTX3002 | Other Identifier | Janssen Scientific Affairs, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48 |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Medical Group | Phoenix | Arizona | 85012 | United States | ||
| The Office of Franco Felizarta, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33999786 | Derived | 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. | |
| 31879782 |
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Out of 97 participants who completed the main study, 80 participants continued into the extension phase and were treated with Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC).
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| ID | Title | Description |
|---|---|---|
| FG000 | D/C/F/TAF | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Study Period (Week 0 to Week 48) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2017 | Dec 19, 2019 |
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Percentage of participants with HIV-1 RNA < 50 copies/mL were reported. |
| Week 24 |
| 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. | Baseline, Weeks 12, 24 and 48 |
| 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. | Up to Week 48 |
| 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. | Up to Week 48 |
| 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. | Up to Week 48 |
| 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. | Up to Week 48 |
| 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. | Up to Day 35 |
| 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). | Baseline (Day 1) |
| 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. | Week 24 and 48 |
| 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. | Up to Week 48 |
| 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. | Up to Week 48 |
| 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. | Up to Week 48 |
| 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. | Weeks 4, 8, 12, 24, 36, and 48 |
| 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. | Weeks 4, 8, 12, 24, 36, and 48 |
| 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. | Weeks 4, 24, and 48 |
| Number of Participants With Hospitalizations | Number of participants with hospitalizations (overnight) was reported. | Up to Week 48 |
| 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. | Up to Week 48 |
| 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. | Up to Week 48 |
| Number of Participants With Emergency Room Visits | Number of participants with emergency room visits was reported. | Up to Week 48 |
| 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. | Up to Week 48 |
| 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. | Up to Week 96 |
| 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. | Up to Week 96 |
| 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. | Up to Week 96 |
| 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. | Weeks 72 and 96 |
| Bakersfield |
| California |
| 93301 |
| United States |
| Jeffrey Goodman Clinic - DBA Los Angeles Gay and Lesbian Center | Los Angeles | California | 90028 | United States |
| Whitman Walker Health | Washington D.C. | District of Columbia | 20009 | United States |
| Midway Immunology and Research Center | Ft. Pierce | Florida | 34982 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Chatham County Health Department | Savannah | Georgia | 31401 | United States |
| The Ruth M. Rothstein CORE Center | Chicago | Illinois | 60612 | United States |
| Saint Michaels Medical Center - Infectious Disease | Newark | New Jersey | 07102 | United States |
| Southwest CARE Center | Albuquerque | New Mexico | 87109 | United States |
| Southwest CARE Center | Santa Fe | New Mexico | 87505 | United States |
| North Texas Infectious Diseases Consultants | Dallas | Texas | 75246 | United States |
| Texas Centers for Infectious Disease Associates | Fort Worth | Texas | 76104 | United States |
| Therapeutic Concepts - Donald R Watkins Foundation | Houston | Texas | 77004 | United States |
| Gordon Crofoot, MD | Houston | Texas | 77098 | United States |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Extension Period (Week 48 to Week 96) |
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| ID | Title | Description |
|---|---|---|
| BG000 | D/C/F/TAF | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 48 |
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| Secondary | 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. | The ITT analysis set included all participants who were randomized and received at least one dose of study treatment in study. Here, n (number analyzed) signifies participants analyzed for this outcome measure (OM) at specified timepoints. | Posted | Mean | Standard Error | log10 HIV-1 RNA copies per mL | Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48 |
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| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 |
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| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. | Posted | Mean | Standard Error | Cells per millimeter cube (cells/mm^3) | Baseline, Weeks 12, 24 and 48 |
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| Secondary | 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. | The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | Up to Week 48 |
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| Secondary | 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. | The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Up to Week 48 |
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| Secondary | 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. | The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Up to Week 48 |
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| Secondary | 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. | The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Up to Week 48 |
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| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Number | Percentage of participants | Up to Day 35 |
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| Secondary | 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). | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this endpoint. | Posted | Number | Percentage of Participants | Baseline (Day 1) |
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| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Number | Percentage of participants | Week 24 and 48 |
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| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Number | Percentage of participants | Up to Week 48 |
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| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Number | Percentage of participants | Up to Week 48 |
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| Secondary | 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. | The modified ITT analysis set included all participants who were randomized and received at least one dose of study treatment and are HIV-1 positive after enrollment. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this OM. Here, n (number analyzed) signifies participants analyzed at specified categories. | Posted | Number | Percentage of participants | Up to Week 48 |
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| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. | Posted | Number | Percentage of participants | Weeks 4, 8, 12, 24, 36, and 48 |
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| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. | Posted | Mean | Standard Deviation | Percentage of participants | Weeks 4, 8, 12, 24, 36, and 48 |
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| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints. | Posted | Mean | Standard Error | Units on a scale | Weeks 4, 24, and 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Hospitalizations | Number of participants with hospitalizations (overnight) was reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Count of Participants | Participants | Up to Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Median | Full Range | Days | Up to Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Count of Participants | Participants | Up to Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Emergency Room Visits | Number of participants with emergency room visits was reported. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. | Posted | Count of Participants | Participants | Up to Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies those participants who were evaluable for the specified categories. | Posted | Median | Full Range | USA dollars | Up to Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. | Posted | Number | Percentage of participants | Up to Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. | Posted | Number | Percentage of participants | Up to Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. | Posted | Number | Percentage of participants | Up to Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | Safety analysis set (SAS) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug up to extension phase. Here 'n' (number analyzed) signifies number of participants with observed virologic response at specified timepoints. | Posted | Number | Percentage of participants | Weeks 72 and 96 |
|
Main study: Up to 48 Weeks; Extension Study: Up to 96 Weeks
The safety analysis was performed on the Intent-to-treat analysis set (ITT) analysis set during main study (Week 0-48) included all the participants who were randomized and received at least one dose of study treatment in the study and safety analysis set (SAS) was used for the analyses during the extension study (Week 48-96) included all participants who received at least 1 dose of study drug and contributed any safety data after the start of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D/C/F/TAF: Main Study | Participants received oral tablet containing Darunavir 800 milligram (mg)/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir alafenamide 10 mg (D/C/F/TAF) as Fixed-dose Combination (FDC) from Day 1 to Week 48. | 0 | 109 | 10 | 109 | 92 | 109 |
| EG001 | D/C/F/TAF: Extension Study | Participants who completed the Week 48 visit were given the opportunity to continue D/C/F/TAF treatment during the extension phase until the D/C/F/TAF FDC tablet became commercially available and was reimbursed, or could be accessed through another source, or until the sponsor terminated clinical development (Up to 96 Weeks). | 0 | 80 | 4 | 80 | 45 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal Injury | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Muscle Rupture | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Motion Sickness | Ear and labyrinth disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypogonadism | Endocrine disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Blindness Transient | Eye disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Anogenital Dysplasia | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Anorectal Discomfort | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Duodenogastric Reflux | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Lip Swelling | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Paraesthesia Oral | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Peripheral Swelling | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Gallbladder Polyp | Hepatobiliary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hepatic Cyst | Hepatobiliary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Acute Hepatitis C | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Acute Sinusitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Anal Chlamydia Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Anorectal Human Papilloma Virus Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cellulitis Staphylococcal | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Chlamydial Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Conjunctivitis Viral | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cytomegalovirus Syndrome | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Genitourinary Chlamydia Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal Gonococcal Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Otitis Externa | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Papilloma Viral Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pharyngeal Chlamydia Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pilonidal Cyst | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Proctitis Gonococcal | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Secondary Syphilis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Skin Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Viral Pharyngitis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Vulvovaginal Candidiasis | Infections and infestations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Anal Injury | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Exposure to Communicable Disease | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Human Bite | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Post-Traumatic Neck Syndrome | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Blood Pressure Diastolic Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Body Temperature Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cardiac Murmur | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abnormal Loss of Weight | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Impaired Fasting Glucose | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Increased Appetite | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Plantar Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Systemic Lupus Erythematosus | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Tenosynovitis Stenosans | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Trigger Finger | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Adrenal Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Seborrhoeic Keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Vulvovaginal Warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abnormal Dreams | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Adjustment Disorder | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Adjustment Disorder with Depressed Mood | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Adjustment Disorder with Mixed Anxiety and Depressed Mood | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Alcoholic Hangover | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Bipolar Disorder | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Depressed Mood | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Drug Abuse | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Initial Insomnia | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Panic Disorder | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Psychotic Disorder | Psychiatric disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cervical Dysplasia | Reproductive system and breast disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Macule | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pityriasis Rosea | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Skin Disorder | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Skin Hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Diastolic Hypertension | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Essential Hypertension | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Systolic Hypertension | Vascular disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 20.0 | Non-systematic Assessment |
|
Study limitations included the open-label, single-arm study design and the small sample size.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior director medical leader | Janssen Scientific Affairs, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2019 | Dec 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| C075889 | Racivir |
Not provided
Not provided
Not provided
| Adverse Event |
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| Other |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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