Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03227861
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Tracking Information
First Submitted Date  ICMJE July 21, 2017
First Posted Date  ICMJE July 24, 2017
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE July 31, 2017
Estimated Primary Completion Date July 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Less Than (<) 50 Copies per Milliliter (Copies/mL) at Week 48 [ Time Frame: Week 48 ]
Food and Drug Administration (FDA) Snapshot Approach is based on the last observed viral load data within the Week 48 window: virologic response is defined as HIV-1 RNA <50 copies/mL; missing HIV-1 RNA is considered as non-response.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03227861 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2017)
  • Change From Baseline in log10 HIV-1 RNA Viral Load at Weeks 2, 4, 8, 12, 24, 36, and 48 [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48 ]
    The change from baseline in log 10 HIV-1 RNA viral load at weeks 2, 4, 8, 12, 24, 36, and 48 will be assessed.
  • Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24 [ Time Frame: Week 24 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at week 24 will be assessed.
  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24, and 48 [ Time Frame: Baseline, Weeks 12, 24, and 48 ]
    The immunologic change will be determined by changes in CD4+ cell count.
  • Percentage of Participants Required Discontinuation After Enrollment Based on Safety Stopping Rules [ Time Frame: Day 10 ]
    Participants meeting any of the below safety stopping rules will be contacted to return to the study site for possible early study treatment discontinuation (ESTD): a) Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula <50 milliliter per minute (mL/min); b) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5* upper limit of normal (ULN); c) serum lipase >= 1.5* ULN; d) positive serum human chorionic gonadotropin pregnancy test (beta-hCG); e) laboratory results that the investigator believes should result in discontinuation of study medication and f) participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.
  • Percentage of Participants Discontinuing Therapy due to Adverse Events (AEs) [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
  • Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0. [ Time Frame: Up to 30-day follow-up visit (maximum of 52 after enrollment) ]
    AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=potentially life-threatening) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
  • Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0. [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    Blood samples for serum chemistry and hematology and a urine sample for urinalysis will be collected at predefined time points for clinical laboratory testing. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
  • Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Drug due to Baseline Resistance Findings [ Time Frame: Up to Day 35 ]
    The percentage of participants meeting resistance stopping rules, requiring discontinuation of study drug due to baseline resistance findings will be reported. Resistance stopping Rule includes participants who do not show full sensitivity to all drugs in the FDC study regimen according to the susceptibility assessment in the GenoSure Prime report will be contacted to return to the study site for early study treatment discontinuation (ESTD). Exception for participants with identified resistance to lamivudine/ emtricitabine (FTC), attributed to the presence of the M184/V mutation alone will be permitted to remain in the study.
  • Percentage of Participants With Baseline Protease (PR), Reverse Transcriptase (RT), and Integrase (INI) (Primary and Secondary) Resistance-Associated Mutation (RAMs) [ Time Frame: Baseline (Day 1) ]
    Percentage of participants with resistance-associated mutations present at baseline will be reported and include mutations in the domain of PR, RT, INI, RAMs as determined by the GenoSure Prime assay.
  • Percentage of Participants Developing RAMs and Loss of Phenotypic Susceptibility, When Available, Upon Meeting Protocol-Defined Virologic Failure [ Time Frame: Up to Week 48 ]
    Participants who experience a protocol-defined virologic failure will be assessed for the development of RAMs and loss of phenotypic susceptibility. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12; b) virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or at any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
  • Percentage of Participants With Protocol-Defined Virologic Failure at Week 24 and Week 48 [ Time Frame: Week 24 and Week 48 ]
    Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
  • Percentage of Participants With Lost-to-Follow-up Throughout the 48 Weeks of Treatment [ Time Frame: Up to Week 48 ]
    The percentage of participants with lost-to-follow-up up to 48 weeks of treatment will be assessed.
  • Percentage of Participants Discontinuing Study Drug for any Reason Other Than Withdrawal of Consent Prior to Week 48 who Have a Documented Clinic Visit With a Healthcare Provider Within 90 Days of Discontinuing Study Drug [ Time Frame: Up to Week 60 (Documented clinic visit within 90 Days of discontinuing study drug) ]
    The percentage of participants discontinuing study drug for any reason other than withdrawal of consent prior to week 48 who have a documented clinic visit with a healthcare provider within 90 days of discontinuing study drug will be reported.
  • Adherence Rates by Pill Count at Weeks 4, 8, 12, 24, 36, and 48 [ Time Frame: Weeks 4, 8, 12, 24, 36, and 48 ]
    Adherence rates will be reported according to the percentage of participants taking >95%, 80-95% and <80% of study drug as assessed by pill count at study visits at Weeks 4, 12, 24, and 48. Participants will be requested to bring unused medication and empty packaging to the study site at each visit, and the amount of study drug dispensed will be compared with the amount returned, and taking into account the period elapsed since the previous visit to assess pill count.
  • Adherence Rates by Participants Self-report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 [ Time Frame: Weeks 4, 8, 12, 24, 36, and 48 ]
    Treatment adherence based on participant self-report using a 4-day recall (that is self report over previous 4 days of treatment) will be summarized by means of descriptive statistics and frequency tabulations at Weeks 4, 8, 12, 24, 36, and 48.
  • Mean Total Scores for the HIV Treatment Satisfaction Questionnaire-Status Version (HIVTSQs) at Weeks 4, 24, and 48 [ Time Frame: Weeks 4, 24, and 48 ]
    The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks.
  • Number of Hospitalizations [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of hospitalizations with HIV-1 infected participants will be assessed up to 52 weeks.
  • Duration of Hospitalizations [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The duration of hospitalizations for HIV-1 infected participants will be assessed up to 52 weeks.
  • Number of Outpatient Visits [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of outpatient visits will be reported up to 52 week.
  • Type of Outpatient Visits [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    Type of outpatient visits (example; general practitioner, specialist) will be reported up to 52 weeks.
  • Number of Emergency Room Visits [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of emergency room visits will be reported up to 52 weeks.
  • Number of Medications Used Throughout the Study [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of medications (including concomitant medication) used throughout the study will be reported.
  • Type of Medications Used Throughout the Study [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The type of medications (including concomitant medication) used throughout the study will be reported.
  • Direct Medical Costs [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The direct medical costs will be calculated up to 52 weeks.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2017)
  • Change From Baseline in log10 HIV-1 RNA Viral Load at Weeks 2, 4, 8, 12, 24, 36, and 48 [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48 ]
    The change from baseline in log 10 HIV-1 RNA viral load at weeks 2, 4, 8, 12, 24, 36, and 48 will be assessed.
  • Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24 [ Time Frame: Week 24 ]
    The percentage of participants with HIV-1 RNA < 50 copies/mL at week 24 will be assessed.
  • Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24, and 48 [ Time Frame: Baseline, Weeks 12, 24, and 48 ]
    The immunologic change will be determined by changes in CD4+ cell count.
  • Percentage of Participants Required Discontinuation After Enrollment Based on Safety Stopping Rules [ Time Frame: Day 10 ]
    Participants meeting any of the below safety stopping rules will be contacted to return to the study site for possible early study treatment discontinuation (ESTD): a) Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula <50 milliliter per minute (mL/min); b) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 2.5* upper limit of normal (ULN); c) serum lipase >= 1.5* ULN; d) positive serum human chorionic gonadotropin pregnancy test (beta-hCG); e) laboratory results that the investigator believes should result in discontinuation of study medication and f) participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.
  • Percentage of Participants Discontinuing Therapy due to Adverse Events (AEs) [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.
  • Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0. [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=potentially life-threatening) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
  • Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0. [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    Blood samples for serum chemistry and hematology and a urine sample for urinalysis will be collected at predefined time points for clinical laboratory testing. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
  • Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Drug due to Baseline Resistance Findings [ Time Frame: Up to Day 35 ]
    The percentage of participants meeting resistance stopping rules, requiring discontinuation of study drug due to baseline resistance findings will be reported. Resistance stopping Rule includes participants who do not show full sensitivity to all drugs in the FDC study regimen according to the susceptibility assessment in the GenoSure Prime report will be contacted to return to the study site for early study treatment discontinuation (ESTD). Exception for participants with identified resistance to lamivudine/ emtricitabine (FTC), attributed to the presence of the M184/V mutation alone will be permitted to remain in the study.
  • Percentage of Participants With Baseline Protease (PR), Reverse Transcriptase (RT), and Integrase (INI) (Primary and Secondary) Resistance-Associated Mutation (RAMs) [ Time Frame: Baseline (Day 1) ]
    Percentage of participants with resistance-associated mutations present at baseline will be reported and include mutations in the domain of PR, RT, INI, RAMs as determined by the GenoSure Prime assay.
  • Percentage of Participants Developing RAMs and Loss of Phenotypic Susceptibility, When Available, Upon Meeting Protocol-Defined Virologic Failure [ Time Frame: Up to Week 48 ]
    Participants who experience a protocol-defined virologic failure will be assessed for the development of RAMs and loss of phenotypic susceptibility. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 3 to 6 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 3 to 6 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 3 to 6 weeks of the HIV-1 RNA result.
  • Percentage of Participants With Protocol-Defined Virologic Failure at Week 24 and Week 48 [ Time Frame: Week 24 and Week 48 ]
    Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 3 to 6 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 3 to 6 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 3 to 6 weeks of the HIV-1 RNA result.
  • Percentage of Participants With Lost-to-Follow-up Throughout the 48 Weeks of Treatment [ Time Frame: Up to Week 48 ]
    The percentage of participants with lost-to-follow-up up to 48 weeks of treatment will be assessed.
  • Percentage of Participants Discontinuing Study Drug for any Reason Other Than Withdrawal of Consent Prior to Week 48 who Have a Documented Clinic Visit With a Healthcare Provider Within 90 Days of Discontinuing Study Drug [ Time Frame: Up to Week 60 (Documented clinic visit within 90 Days of discontinuing study drug) ]
    The percentage of participants discontinuing study drug for any reason other than withdrawal of consent prior to week 48 who have a documented clinic visit with a healthcare provider within 90 days of discontinuing study drug will be reported.
  • Adherence Rates by Pill Count at Weeks 4, 8, 12, 24, 36, and 48 [ Time Frame: Weeks 4, 8, 12, 24, 36, and 48 ]
    Adherence rates will be reported according to the percentage of participants taking >95%, 80-95% and <80% of study drug as assessed by pill count at study visits at Weeks 4, 12, 24, and 48. Participants will be requested to bring unused medication and empty packaging to the study site at each visit, and the amount of study drug dispensed will be compared with the amount returned, and taking into account the period elapsed since the previous visit to assess pill count.
  • Adherence Rates by Participants Self-report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48 [ Time Frame: Weeks 4, 8, 12, 24, 36, and 48 ]
    Treatment adherence based on participant self-report using a 4-day recall (that is self report over previous 4 days of treatment) will be summarized by means of descriptive statistics and frequency tabulations at Weeks 4, 8, 12, 24, 36, and 48.
  • Mean Total Scores for the HIV Treatment Satisfaction Questionnaire-Status Version (HIVTSQs) at Weeks 4, 24, and 48 [ Time Frame: Weeks 4, 24, and 48 ]
    The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks.
  • Number of Hospitalizations [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of hospitalizations with HIV-1 infected participants will be assessed up to 52 weeks.
  • Duration of Hospitalizations [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The duration of hospitalizations for HIV-1 infected participants will be assessed up to 52 weeks.
  • Number of Outpatient Visits [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of outpatient visits will be reported up to 52 week.
  • Type of Outpatient Visits [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    Type of outpatient visits (example; general practitioner, specialist) will be reported up to 52 weeks.
  • Number of Emergency Room Visits [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of emergency room visits will be reported up to 52 weeks.
  • Number of Medications Used Throughout the Study [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The number of medications (including concomitant medication) used throughout the study will be reported.
  • Type of Medications Used Throughout the Study [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The type of medications (including concomitant medication) used throughout the study will be reported.
  • Direct Medical Costs [ Time Frame: Up to 30-day follow-up visit (maximum of 52 weeks after enrollment) ]
    The direct medical costs will be calculated up to 52 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1
Intervention  ICMJE Drug: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.
Study Arms  ICMJE Experimental: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit.
Intervention: Drug: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 27, 2018)
109
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2017)
100
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date July 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03227861
Other Study ID Numbers  ICMJE CR108345
TMC114FD2HTX3002 ( Other Identifier: Janssen Scientific Affairs, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Scientific Affairs, LLC
Study Sponsor  ICMJE Janssen Scientific Affairs, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
PRS Account Janssen Scientific Affairs, LLC
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP