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Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021) (DRIVE-AHEAD)

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Doravirine, Tenofovir, Lamivudine
ATRIPLA™
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus (HIV)

Eligibility Criteria

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

Inclusion Criteria:

  • Is HIV-1 positive as determined by a positive result on an enzyme-immunoassay, has screening plasma HIV-1 RNA (determined by the central laboratory) ≥1000 copies/mL within 45 days prior to the treatment phase of this study, and has HIV treatment indicated based on physician assessment
  • Has never received antiretroviral therapy (ART)
  • Is highly unlikely to either become pregnant or impregnate a partner

Exclusion Criteria:

  • Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study
  • Is a user of recreational or illicit drugs or has a recent history of alcohol/drug abuse
  • Has been treated for a viral infection other than HIV-1 (e.g., hepatitis B) with an agent that is active against HIV-1
  • Has participated in a study with an investigational drug/device within 30 days prior to Screening
  • Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
  • Has a current (active) diagnosis of acute hepatitis due to any cause (note: participants with chronic hepatitis B and C may enter the study as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function)
  • Is a female who is pregnant, breastfeeding, or expecting to conceive
  • Is a female and is expecting to donate eggs or is male and is expecting to donate sperm (investigators will provide appropriate guidance regarding egg and/or sperm donation after completion of the study treatment regimen)
  • Has evidence of decompensated liver disease manifested by the presence of or a history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver diseases, or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score > 9

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Doravirine, Tenofovir, Lamivudine

    ATRIPLA™

    Arm Description

    Treatment-naive HIV-infected participants will receive doravirine, tenofovir, lamivudine, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding.

    Treatment-naive HIV-infected participants will receive ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to doravirine, tenofovir, lamivudine q.d. by mouth for 96 weeks in order to maintain blinding.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
    The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach in which all missing data are considered treatment failures, regardless of the reason.
    Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
    The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included "dizziness", "sleep disorders and disturbances", and "altered sensorium" (including disturbance in attention).

    Secondary Outcome Measures

    Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
    The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 96 will be determined. Plasma HIV-1 RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) will be used for efficacy analyses.
    Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
    The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach in which all missing data are considered treatment failures, regardless of the reason.
    Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96
    The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 96 will be determined. Plasma HIV-1 RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) will be used for efficacy analyses.
    Change From Baseline in CD4 Cell Counts at Week 48
    The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
    Change From Baseline in CD4 Cell Counts at Week 96
    The mean change from baseline in CD4 cell counts at Week 96 will be assessed using the Observed Failure (OF) approach. With the OF approach, baseline values will be carried forward for participants who discontinued prior to Week 96 due to lack of efficacy. Cell counts at Baseline and Week 96 will be measured and expressed as cells/mm^3, and percent change will then be calculated as [(Baseline counts - Week 96 counts)*100]. CD4 cell counts will be quantified by a central laboratory using a commercially available assay.
    Percentage of Participants Experiencing ≥1 AE
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    Percentage of Participants With Tier-2 Neuropsychiatric AEs
    The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included "depression and suicide/self-injury" and "psychosis and psychotic disorders".
    Change From Baseline in Fasting LDL-C at Week 48
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Change From Baseline in Fasting Non-HDL-C at Week 48
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Change From Baseline in Fasting Cholesterol at Week 48
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Change From Baseline in Fasting Triglycerides at Week 48
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Change From Baseline in Fasting HDL-C at Week 48
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48
    The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed.
    Percentage of Participants With HIV-1 RNA BLoQ at Week 96
    The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 96 will be determined. Plasma HIV RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. Data will be handled as observed.
    Plasma Concentration of Doravirine at Week 48
    Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose.

    Full Information

    First Posted
    March 26, 2015
    Last Updated
    September 22, 2023
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02403674
    Brief Title
    Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)
    Acronym
    DRIVE-AHEAD
    Official Title
    A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 5, 2015 (Actual)
    Primary Completion Date
    March 20, 2017 (Actual)
    Study Completion Date
    September 7, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the antiretroviral activity of doravirine, tenofovir, lamivudine (MK-1439A), a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing doravirine (MK-1439) 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with human immunodeficiency virus (HIV). The primary hypothesis is that doravirine, tenofovir, lamivudine q.d. is non-inferior to ATRIPLA™ q.d. as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL (by the Abbott RealTime HIV-1 Assay) at Week 48. This study has a total duration of 192 weeks, including a 96-week double-blind period and a 96-week open-label period. The present results are based on the first 48 weeks of this ongoing study.
    Detailed Description
    Participants in Australia, Colombia, Guatemala, Honduras, Israel, New Zealand, Peru, Russia, South Africa, and Thailand who are deriving benefit from doravirine, tenofovir, lamivudine are also eligible to continue receiving study drug during additional open-label extensions which will last for 2 years or until drug is available locally, whichever comes first.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus (HIV)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    734 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Doravirine, Tenofovir, Lamivudine
    Arm Type
    Experimental
    Arm Description
    Treatment-naive HIV-infected participants will receive doravirine, tenofovir, lamivudine, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 96 weeks in order to maintain blinding.
    Arm Title
    ATRIPLA™
    Arm Type
    Active Comparator
    Arm Description
    Treatment-naive HIV-infected participants will receive ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg (equivalent to 245 mg tenofovir disoproxil), q.d. by mouth for 96 weeks. Participants will also take 1 placebo tablet matched to doravirine, tenofovir, lamivudine q.d. by mouth for 96 weeks in order to maintain blinding.
    Intervention Type
    Drug
    Intervention Name(s)
    Doravirine, Tenofovir, Lamivudine
    Other Intervention Name(s)
    MK-1439A
    Intervention Description
    One doravirine, tenofovir, lamivudine tablet taken q.d. by mouth.
    Intervention Type
    Drug
    Intervention Name(s)
    ATRIPLA™
    Intervention Description
    One ATRIPLA™ tablet taken q.d. by mouth
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablets matched to ATRIPLA® or Doravirine, Tenofovir, Lamivudine.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
    Description
    The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach in which all missing data are considered treatment failures, regardless of the reason.
    Time Frame
    Week 48
    Title
    Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
    Description
    The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included "dizziness", "sleep disorders and disturbances", and "altered sensorium" (including disturbance in attention).
    Time Frame
    Up to Week 48
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
    Description
    The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 96 will be determined. Plasma HIV-1 RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) will be used for efficacy analyses.
    Time Frame
    Week 96
    Title
    Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
    Description
    The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach in which all missing data are considered treatment failures, regardless of the reason.
    Time Frame
    Week 48
    Title
    Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96
    Description
    The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 96 will be determined. Plasma HIV-1 RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) "snapshot" approach (i.e., all missing data handled as treatment failures, regardless of the reason) will be used for efficacy analyses.
    Time Frame
    Week 96
    Title
    Change From Baseline in CD4 Cell Counts at Week 48
    Description
    The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.
    Time Frame
    Baseline (Day 1) and Week 48
    Title
    Change From Baseline in CD4 Cell Counts at Week 96
    Description
    The mean change from baseline in CD4 cell counts at Week 96 will be assessed using the Observed Failure (OF) approach. With the OF approach, baseline values will be carried forward for participants who discontinued prior to Week 96 due to lack of efficacy. Cell counts at Baseline and Week 96 will be measured and expressed as cells/mm^3, and percent change will then be calculated as [(Baseline counts - Week 96 counts)*100]. CD4 cell counts will be quantified by a central laboratory using a commercially available assay.
    Time Frame
    Baseline (Day 1) and Week 96
    Title
    Percentage of Participants Experiencing ≥1 AE
    Description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    Time Frame
    Up to Week 48
    Title
    Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
    Description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    Time Frame
    Up to Week 48
    Title
    Percentage of Participants With Tier-2 Neuropsychiatric AEs
    Description
    The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included "depression and suicide/self-injury" and "psychosis and psychotic disorders".
    Time Frame
    Up to Week 48
    Title
    Change From Baseline in Fasting LDL-C at Week 48
    Description
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Time Frame
    Baseline (Day 1) and Week 48
    Title
    Change From Baseline in Fasting Non-HDL-C at Week 48
    Description
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Time Frame
    Baseline (Day 1) and Week 48
    Title
    Change From Baseline in Fasting Cholesterol at Week 48
    Description
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Time Frame
    Baseline (Day 1) and Week 48
    Title
    Change From Baseline in Fasting Triglycerides at Week 48
    Description
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Time Frame
    Baseline (Day 1) and Week 48
    Title
    Change From Baseline in Fasting HDL-C at Week 48
    Description
    The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.
    Time Frame
    Baseline (Day 1) and Week 48
    Title
    Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48
    Description
    The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed.
    Time Frame
    Week 48
    Title
    Percentage of Participants With HIV-1 RNA BLoQ at Week 96
    Description
    The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 96 will be determined. Plasma HIV RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. Data will be handled as observed.
    Time Frame
    Week 48
    Title
    Plasma Concentration of Doravirine at Week 48
    Description
    Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose.
    Time Frame
    0 hours post-dose and 2 hours post-dose on Week 48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Is HIV-1 positive as determined by a positive result on an enzyme-immunoassay, has screening plasma HIV-1 RNA (determined by the central laboratory) ≥1000 copies/mL within 45 days prior to the treatment phase of this study, and has HIV treatment indicated based on physician assessment Has never received antiretroviral therapy (ART) Is highly unlikely to either become pregnant or impregnate a partner Exclusion Criteria: Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study Is a user of recreational or illicit drugs or has a recent history of alcohol/drug abuse Has been treated for a viral infection other than HIV-1 (e.g., hepatitis B) with an agent that is active against HIV-1 Has participated in a study with an investigational drug/device within 30 days prior to Screening Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study Has a current (active) diagnosis of acute hepatitis due to any cause (note: participants with chronic hepatitis B and C may enter the study as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function) Is a female who is pregnant, breastfeeding, or expecting to conceive Is a female and is expecting to donate eggs or is male and is expecting to donate sperm (investigators will provide appropriate guidance regarding egg and/or sperm donation after completion of the study treatment regimen) Has evidence of decompensated liver disease manifested by the presence of or a history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver diseases, or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score > 9
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    33336698
    Citation
    Orkin C, Squires KE, Molina JM, Sax PE, Sussmann O, Lin G, Kumar S, Hanna GJ, Hwang C, Martin E, Teppler H. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz/Emtricitabine/TDF in Treatment-naive Adults With Human Immunodeficiency Virus Type 1 Infection: Week 96 Results of the Randomized, Double-blind, Phase 3 DRIVE-AHEAD Noninferiority Trial. Clin Infect Dis. 2021 Jul 1;73(1):33-42. doi: 10.1093/cid/ciaa822.
    Results Reference
    derived
    PubMed Identifier
    31121015
    Citation
    Orkin C, Molina JM, Lombaard J, DeJesus E, Rodgers A, Kumar S, Martin E, Hanna G, Hwang C. Once-daily Doravirine in Human Immunodeficiency Virus Type 1-Infected, Antiretroviral-naive Adults: An Integrated Efficacy Analysis. Clin Infect Dis. 2020 Mar 17;70(7):1344-1352. doi: 10.1093/cid/ciz424. Erratum In: Clin Infect Dis. 2020 Jan 2;70(2):360.
    Results Reference
    derived
    PubMed Identifier
    31121013
    Citation
    Thompson M, Orkin C, Molina JM, Sax P, Cahn P, Squires K, Xu X, Rodgers A, Kumar S, Teppler H, Martin E, Hanna G, Hwang C. Once-daily Doravirine for Initial Treatment of Adults Living With Human Immunodeficiency Virus-1: An Integrated Safety Analysis. Clin Infect Dis. 2020 Mar 17;70(7):1336-1343. doi: 10.1093/cid/ciz423.
    Results Reference
    derived
    PubMed Identifier
    30184165
    Citation
    Orkin C, Squires KE, Molina JM, Sax PE, Wong WW, Sussmann O, Kaplan R, Lupinacci L, Rodgers A, Xu X, Lin G, Kumar S, Sklar P, Nguyen BY, Hanna GJ, Hwang C, Martin EA; DRIVE-AHEAD Study Group. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment-naive Adults With Human Immunodeficiency Virus-1 Infection: Week 48 Results of the DRIVE-AHEAD Trial. Clin Infect Dis. 2019 Feb 1;68(4):535-544. doi: 10.1093/cid/ciy540.
    Results Reference
    derived
    Links:
    URL
    http://www.merckclinicaltrials.com
    Description
    Merck Clinical Trials Information

    Learn more about this trial

    Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021)

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