Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir,... | NCT02652260 | Trialant
NCT02652260
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Feb 7, 2025Actual
Enrollment
86Actual
Phase
Phase 2
Conditions
HIV-1
Central Nervous System
Interventions
Doravirine, Tenofovir, Lamivudine - Blinded
Doravirine, Tenofovir, Lamivudine - Open-Label
ATRIPLA^TM
Placebo to ATRIPLA™
Placebo to Doravirine, Tenofovir, Lamivudine
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02652260
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1439A-028
Secondary IDs
ID
Type
Description
Link
MK-1439A-028
Other Identifier
Merck Protocol Number
2015-003617-18
EudraCT Number
Brief Title
Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)
Official Title
Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Subjects.
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jan 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 4, 2016Actual
Primary Completion Date
Aug 14, 2018Actual
Completion Date
Feb 7, 2024Actual
First Submitted Date
Jan 8, 2016
First Submission Date that Met QC Criteria
Jan 8, 2016
First Posted Date
Jan 11, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 16, 2019
Results First Submitted that Met QC Criteria
Aug 26, 2019
Results First Posted Date
Aug 29, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 21, 2025
Last Update Posted Date
Feb 7, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study aims to evaluate a switch from fixed dose combination (FDC) treatment with ATRIPLA^TM for 12 weeks prior to screening to FDC treatment with Doravirine, Tenofovir, Lamivudine (MK-1439A) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1)-infected participants. The primary hypothesis is that switching from ATRIPLA^TM to Doravirine, Tenofovir, Lamivudine results in a lower proportion of participants with at least one CNS toxicity of at least Grade 2 intensity at Week 12 than continuation of ATRIPLA^TM treatment.
Detailed Description
Not provided
Conditions Module
Conditions
HIV-1
Central Nervous System
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
86Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Immediate Switch to Doravirine, Tenofovir, Lamivudine
Experimental
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded doravirine, tenofovir, lamivudine orally, once daily for 12 weeks, followed by open-label doravirine, tenofovir, lamivudine orally, once daily for an additional 12 weeks. Participants who meet eligibility criteria can enter study extension 1 to receive open-label doravirine, tenofovir, lamivudine for an additional 96 weeks. Participants who meet eligibility criteria can enter study extension 2 to receive open-label doravirine, tenofovir, lamivudine, with a maximum total duration of treatment of 216 weeks. Participants who meet eligibility criteria can enter study extension 3 to receive open-label doravirine, tenofovir, lamivudine, with a maximum total duration of treatment of 312 weeks.
Deferred Switch to Doravirine, Tenofovir, Lamivudine
Experimental
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label doravirine, tenofovir, lamivudine orally, once daily for 24 weeks. Participants who meet eligibility criteria can enter study extension 1 to receive open-label doravirine, tenofovir, lamivudine for an additional 96 weeks. Participants who meet eligibility criteria can enter study extension 2 to receive open-label doravirine, tenofovir, lamivudine, with a maximum total duration of treatment of 228 weeks. Participants who meet eligibility criteria can enter study extension 3 to receive open-label doravirine, tenofovir, lamivudine, with a maximum total duration of treatment of 324 weeks.
Drug: Placebo to Doravirine, Tenofovir, Lamivudine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Doravirine, Tenofovir, Lamivudine - Blinded
Drug
A single tablet FDC containing doravirine 100 mg, lamivudine (3TC) 300 mg and tenofovir disoproxil fumarate (TDF) 300 mg administered orally, once daily for 12 weeks during the Blinded period
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
is taking ATRIPLA™, generic versions of ATRIPLA™, or the components of ATRIPLA™ (EFV,TDF plus emtricitabine),
has documentation of HIV-1 ribonucleic acid (RNA) < 50 copies/mL during the 12 weeks prior to screening while on ATRIPLA™.
has plasma HIV-1 RNA levels below the limits of quantification (BLoQ) at the screening visit.
if genotyped prior to starting initial antiretroviral regimen, must have no known resistance to any of the study agents
has at least one EFV-associated CNS toxicities of Grade 2 or worse intensity both at the time of screening and at Study Day 1
is highly unlikely to become pregnant or to impregnate a partner
To be eligible for study extension 1, participants from Immediate Switch Group (ISG) must have completed Study Week 24, and benefited from study participation; participants from Deferred Switch Group (DSG) must have completed Study Week 36, and benefited from study participation as determined by the investigator
To be eligible for study extension 2, participants from ISG must have completed Study Week 120, and benefited from study participation; participants from DSG must have completed Study Week 132, and benefited from study participation as determined by the investigator
Exclusion Criteria:
is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
has ongoing Grade 4 CNS toxicity during screening period that requires a prompt change in ART
has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 including, but not limited to, adefovir, emtricitabine, entecavir, lamivudine or tenofovir.
has documented or known resistance to study drugs including doravirine, lamivudine, and/or tenofovir
has participated in, or anticipates participating in a study with an investigational compound/device within 30 days prior to signing informed consent
has used systemic immunosuppressive therapy or immune modulators or anticipates using them within 30 days prior to this study
requires or anticipates requiring any of the prohibited medications
has significant hypersensitivity or other contraindication to any of the components of the study drugs
has a current (active) diagnosis of acute hepatitis due to any cause.
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.
is pregnant, breastfeeding, or expecting to conceive.
female is expecting to donate eggs (at any time during the study) or male is expecting to donate sperm (at any time during the study).
Nelson M, Winston A, Hill A, Mngqibisa R, Bassa A, Orkin C, Rassool M, Rodgers A, Teal V, Kumar S, Teppler H. Efficacy, safety and central nervous system effects after switch from efavirenz/tenofovir/emtricitabine to doravirine/tenofovir/lamivudine. AIDS. 2021 Apr 1;35(5):759-767. doi: 10.1097/QAD.0000000000002804.
Out of 112 participants screened, 86 were randomized and received study treatment.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening were switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks. Eligible participants from Base Study (Day 1 to Week 24) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 24 to 120), Extension 2 (Weeks 120 to 216), and Extension 3 (Weeks 216 to 312).
Periods
Title
Milestones
Reasons Not Completed
Base Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Oct 31, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Ireland
South Africa
United Kingdom
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Immediate Switch to Doravirine, Tenofovir, Lamivudine
MK-1439A
Doravirine, Tenofovir, Lamivudine - Open-Label
Drug
A single-tablet FDC containing doravirine 100 mg, 3TC 300 mg and TDF 300 mg administered orally, once daily for either 12 or 24 weeks during the Open-Label Period; also an additional 96 weeks during the Open-Label extension period 1; a maximum total duration of treatment of 228 weeks during the Open-Label extension period 2; and a maximum total duration of treatment of 324 weeks during the Open-Label extension period 3.
Deferred Switch to Doravirine, Tenofovir, Lamivudine
Immediate Switch to Doravirine, Tenofovir, Lamivudine
MK-1439A
ATRIPLA^TM
Drug
A single tablet FDC containing efavirenz (EFV) 600 mg, emtricitabine (FTC) 200 mg, and TDF 300 mg administered orally, once daily for 12 weeks during the Blinded period
Deferred Switch to Doravirine, Tenofovir, Lamivudine
Placebo to ATRIPLA™
Drug
A single placebo to ATRIPLA™ tablet administered orally, once daily for 12 weeks during the Blinded period
Immediate Switch to Doravirine, Tenofovir, Lamivudine
Placebo to Doravirine, Tenofovir, Lamivudine
Drug
A single placebo to doravirine, tenofovir, lamivudine tablet administered orally, once daily for 12 weeks during the Blinded period
Deferred Switch to Doravirine, Tenofovir, Lamivudine
Week 4
Change From Baseline in CNS Toxicity Score at Week 4
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms.
Baseline and Week 4
Change From Baseline in CNS Toxicity Score at Week 12
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms.
Baseline and Week 12
Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. For the Immediate Switch Group (ISG) time of switch was study Day 1, and week 24 post-switch was week 24. For the Delayed Switch Group (DSG) time of switch was study week 12, and week 24 post-switch was week 36.
Baseline (time of switch) and 24 weeks post-switch
CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A higher CNS score indicates worse symptoms. A positive change in CNS score indicates worsening symptoms. A negative change indicates improvement in symptoms. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.
Baseline (time of switch) and 24 weeks post-switch
Change From Baseline in Fasting Lipids at Week 12
Blood was collected under fasting conditions on Day 1 and on week 12 in order to determine the concentration of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride.
Baseline (study Day 1) and study week 12
Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
Blood was collected under fasting conditions at time of switch and 24 weeks post-switch in order to determine the change from baseline of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.
Baseline (time of switch) and 24 weeks post-switch
Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups
Blood was collected under fasting conditions at 24 weeks post-switch in order to determine the HIV-1 RNA. For the ISG week 24 post-switch was week 24. For the DSG week 24 post-switch was week 36.
24 weeks post-switch
Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups
Blood was collected at time of switch and at 24 weeks post-switch in order to determine the CD4 T-cell count. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.
Baseline (time of switch) and 24 weeks post-switch
Number of Participants With One or More Adverse Events (AEs) Through Study Week 12
An adverse event (AE) is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Up to Week 12
Number of Participants With One or More Drug-related AEs Through Study Week 12
An adverse event (AE) is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug.
Up to Week 12
Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose.
Up to Week 12
Number of Participants With One or More Drug-related SAEs Through Study Week 12
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug.
Up to Week 12
Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Up to Week 12
Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
24 weeks post-switch
Number of Participants With One or More Drug-related AEs for the Combined Treatment Groups 24 Weeks After the Switch
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
24 weeks post-switch
Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
24 weeks post-switch
Number of Participants With One or More Drug-related SAEs for the Combined Treatment Groups 24 Weeks After the Switch
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
24 weeks post-switch
Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
24 weeks post-switch
FG001
Deferred Switch to MK-1439A
Participants continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks (Day 1 to Week 12), followed by open-label MK-1439A orally, once daily for 24 weeks (Weeks 12 to 36). Eligible participants from Base Study (Day 1 to Week 36) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 36 to 132), Extension 2 (Weeks 132 to 228), and Extension 3 (Weeks 228 to 324).
FG00043 subjects
FG00143 subjects
Switched Over to MK-1439A
FG0000 subjects
FG00142 subjects
COMPLETED
FG00043 subjects
FG00141 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
Type
Comment
Reasons
Pregnancy
FG0000 subjects
FG0011 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
Study Extension 1 (Open-Label)
Type
Comment
Milestone Data
STARTED
FG00043 subjects
FG00141 subjects
COMPLETED
FG00039 subjects
FG00134 subjects
NOT COMPLETED
FG0004 subjects
FG0017 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
Pregnancy
FG0001 subjects
FG001
Study Extension 2 (Open-Label)
Type
Comment
Milestone Data
STARTED
Not all study participants continued into optional study extension 2
FG00039 subjects
FG00133 subjects
COMPLETED
FG00017 subjects
FG00119 subjects
NOT COMPLETED
FG00022 subjects
FG00114 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
Availability of study drug locally
FG00018 subjects
FG001
Study Extension 3 (Open-Label)
Type
Comment
Milestone Data
STARTED
FG00017 subjects
FG00119 subjects
COMPLETED
FG00010 subjects
FG0018 subjects
NOT COMPLETED
FG0007 subjects
FG00111 subjects
Type
Comment
Reasons
Physician Decision
FG0007 subjects
FG00110 subjects
Pregnancy
FG0000 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks. Eligible participants from Base Study (Day 1 to Week 24) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 24 to 120), Extension 2 (Weeks 120 to 216), and Extension 3 (Weeks 216 to 312).
BG001
Deferred Switch to MK-1439A
Participants continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks (Day 1 to Week 12), followed by open-label MK-1439A orally, once daily for 24 weeks (Weeks 12 to 36). Eligible participants from Base Study (Day 1 to Week 36) may have entered open-label optional study extensions to receive MK-1439A once daily during Study Extension 1 (Weeks 36 to 132), Extension 2 (Weeks 132 to 228), and Extension 3 (Weeks 228 to 324).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00043
BG00143
BG00286
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG00043
ParticipantsBG00143
ParticipantsBG00286
Title
Measurements
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00043
ParticipantsBG00143
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00043
ParticipantsBG00143
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00043
ParticipantsBG00143
ParticipantsBG002
CNS Toxicity Percentage Of Maximum Score
Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A higher CNS score indicates worsening symptoms.
Mean
Standard Deviation
Percentage of maximum score
Title
Denominators
Categories
ParticipantsBG00043
ParticipantsBG001
Fasting Lipids
Mean concentrations of low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride.
All randomized participants who received at least one dose of study treatment.
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
LDL Cholesterol
ParticipantsBG00036
ParticipantsBG00141
ParticipantsBG002
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 at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Participants
OG00043
OG00143
Title
Denominators
Categories
Title
Measurements
OG00041.9
OG00137.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference: Immediate Switch minus Delayed Switch
Miettinen and Nurminen
0.331
Estimated Difference
4.65
2-Sided
95
-15.92
24.85
Other
The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.
The 95% confidence interval (CI) was calculated by the method of Miettinen and Nurminen.
Secondary
Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
Posted
Number
Percentage of participants
Week 4
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
Change From Baseline in CNS Toxicity Score at Week 4
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
Posted
Mean
95% Confidence Interval
Percentage of maximum score
Baseline and Week 4
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Secondary
Change From Baseline in CNS Toxicity Score at Week 12
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
Posted
Mean
95% Confidence Interval
Percentage of maximum score
Baseline and Week 12
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Secondary
Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. For the Immediate Switch Group (ISG) time of switch was study Day 1, and week 24 post-switch was week 24. For the Delayed Switch Group (DSG) time of switch was study week 12, and week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
Posted
Number
Percentage of participants
Baseline (time of switch) and 24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups: Time of Switch
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A higher CNS score indicates worse symptoms. A positive change in CNS score indicates worsening symptoms. A negative change indicates improvement in symptoms. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
Posted
Mean
95% Confidence Interval
Percentage of maximum score
Baseline (time of switch) and 24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups: Time of Switch
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
Change From Baseline in Fasting Lipids at Week 12
Blood was collected under fasting conditions on Day 1 and on week 12 in order to determine the concentration of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride.
All randomized participants who received at least one dose of study treatment, and have required lipid data.
Posted
Mean
Standard Deviation
mg/dL
Baseline (study Day 1) and study week 12
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Participants
Secondary
Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
Blood was collected under fasting conditions at time of switch and 24 weeks post-switch in order to determine the change from baseline of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have required lipid data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
Posted
Mean
Standard Deviation
mg/dL
Baseline (time of switch) and 24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Secondary
Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups
Blood was collected under fasting conditions at 24 weeks post-switch in order to determine the HIV-1 RNA. For the ISG week 24 post-switch was week 24. For the DSG week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have required HIV-1 RNA data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Participants
OG000
Secondary
Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups
Blood was collected at time of switch and at 24 weeks post-switch in order to determine the CD4 T-cell count. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have required CD4 T-cell data. Based on the protocol-specified plan, the combined treatment groups was analyzed.
Posted
Mean
95% Confidence Interval
cells/mm^3
Baseline (time of switch) and 24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Participants
Secondary
Number of Participants With One or More Adverse Events (AEs) Through Study Week 12
An adverse event (AE) is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
All randomized participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Up to Week 12
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
Number of Participants With One or More Drug-related AEs Through Study Week 12
An adverse event (AE) is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug.
All randomized participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Up to Week 12
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose.
All randomized participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Up to Week 12
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Secondary
Number of Participants With One or More Drug-related SAEs Through Study Week 12
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug.
All randomized participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Up to Week 12
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Secondary
Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
All randomized participants who received at least one dose of study treatment.
Posted
Count of Participants
Participants
Up to Week 12
ID
Title
Description
OG000
Immediate Switch to MK-1439A
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
OG001
Deferred Switch to MK-1439A
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
Posted
Count of Participants
Participants
24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
Number of Participants With One or More Drug-related AEs for the Combined Treatment Groups 24 Weeks After the Switch
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
Posted
Count of Participants
Participants
24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
Posted
Count of Participants
Participants
24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
Number of Participants With One or More Drug-related SAEs for the Combined Treatment Groups 24 Weeks After the Switch
A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
Posted
Count of Participants
Participants
24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Secondary
Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch
An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.
Posted
Count of Participants
Participants
24 weeks post-switch
ID
Title
Description
OG000
Combined Treatment Groups
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Time Frame
Up to approximately 326 weeks
Description
All cause-mortality was reported on all allocated participants. Serious and non-serious AEs were reported for all allocated participants who received ≥1 dose of study treatment. Per protocol, serious adverse events and all-cause mortality were collected up to 326 weeks, and non-serious adverse event data were collected up to 134 weeks.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Immediate Switch to MK-1439A (Day 1 to Week 24)
Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening switched to blinded doravirine, tenofovir, lamivudine orally, once daily for 12 weeks, followed by open-label doravirine, tenofovir, lamivudine orally, once daily for an additional 12 weeks
0
43
0
43
29
43
EG001
Deferred Switch to MK-1439A (Day 1 to Week 12)
Participants continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks.
0
43
0
43
25
43
EG002
Deferred Switch to MK-1439A (Week 12-36)
Participants who continued their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks switched to open-label doravirine, tenofovir, lamivudine orally, once daily for a total of 24 weeks (Week 12 - Week 36).
0
42
1
42
26
42
EG003
Immediate Switch to MK-1439A EXT 1 (Week 24-120)
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 24 - Week 120)
0
43
6
43
31
43
EG004
Deferred Switch to MK-1439A EXT 1 (Week 36-132)
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 36 - Week 132)
0
41
2
41
33
41
EG005
Immediate Switch to MK-1439A EXT 2 (Week 120-216)
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 120 - Week 216)
0
39
3
39
0
0
EG006
Deferred Switch to MK-1439A EXT 2 (Week 132-228)
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 132 - Week 228)
0
33
1
33
0
0
EG007
Immediate Switch to MK-1439A EXT 3 (Week 216-312)
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 216 - Week 312)
0
17
2
17
0
0
EG008
Deferred Switch to MK-1439A EXT 3 (Week 228-324)
One doravirine, tenofovir, lamivudine taken q.d. by mouth for an additional 96 weeks (Week 228 - Week 324)
0
19
0
19
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal hernia
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG0031 events1 affected43 at risk
EG0040 events0 affected41 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected33 at risk
EG0070 events0 affected17 at risk
EG0080 events0 affected19 at risk
Appendicitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Wound sepsis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected42 at risk
EG003
Stab wound
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0006 events6 affected43 at risk
EG0013 events3 affected43 at risk
EG0024 events4 affected42 at risk
EG0031 events1 affected43 at risk
EG0044 events4 affected41 at risk
EG0050 events0 affected0 at risk
EG0060 events0 affected0 at risk
EG0070 events0 affected0 at risk
EG0080 events0 affected0 at risk
Nausea
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0005 events5 affected43 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected42 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events1 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0010 events0 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0011 events1 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0012 events2 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0006 events4 affected43 at risk
EG0016 events6 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Viral infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0010 events0 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0010 events0 affected43 at risk
EG0021 events1 affected42 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0008 events7 affected43 at risk
EG0011 events1 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0004 events3 affected43 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected42 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0004 events3 affected43 at risk
EG0014 events4 affected43 at risk
EG0024 events4 affected42 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0007 events7 affected43 at risk
EG0015 events5 affected43 at risk
EG0025 events5 affected42 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG00013 events11 affected43 at risk
EG0019 events7 affected43 at risk
EG0023 events3 affected42 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0008 events6 affected43 at risk
EG0013 events3 affected43 at risk
EG0025 events5 affected42 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0005 events5 affected43 at risk
EG0013 events3 affected43 at risk
EG0023 events3 affected42 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0004 events3 affected43 at risk
EG0012 events2 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0003 events2 affected43 at risk
EG0012 events2 affected43 at risk
EG0027 events7 affected42 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0011 events1 affected43 at risk
EG0023 events3 affected42 at risk
EG003
Depressed mood
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected43 at risk
EG0012 events2 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0003 events3 affected43 at risk
EG0011 events1 affected43 at risk
EG0024 events4 affected42 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0009 events8 affected43 at risk
EG00110 events7 affected43 at risk
EG0026 events6 affected42 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0002 events2 affected43 at risk
EG0010 events0 affected43 at risk
EG0022 events2 affected42 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected43 at risk
EG0012 events2 affected43 at risk
EG0020 events0 affected42 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0004 events3 affected43 at risk
EG0011 events1 affected43 at risk
EG0021 events1 affected42 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Treatment Difference: Immediate Switch minus Delayed Switch
Estimated Difference
-18.61
2-Sided
95
-38.14
2.51
Other
The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.
The 95% CI was calculated by the method of Miettinen and Nurminen.
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Participants
OG00043
OG00143
Title
Denominators
Categories
Title
Measurements
OG000-17.6(-23.4 to -11.8)
OG001-15.6(-22.0 to -9.2)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference: Immediate Switch minus Delayed Switch
Estimated Difference
-2.0
2-Sided
95
-10.5
6.5
Other
The 95% CI was based on a t-distribution.
Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Participants
OG00043
OG00143
Title
Denominators
Categories
Title
Measurements
OG000-18.1(-22.9 to -13.3)
OG001-21.7(-27.9 to -15.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment Difference: Immediate Switch minus Delayed Switch
Estimated Difference
3.6
2-Sided
95
-4.1
11.3
Other
The 95% CI was calculated by the method of Miettinen and Nurminen.
OG001
Combined Treatment Groups: Week 24 Post-Switch
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Participants
OG00086
OG00186
Title
Denominators
Categories
Title
Measurements
OG00068.6
OG00130.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from time of switch to 24 weeks post-switch: Treatment difference in percent response
Difference in Percentage
-38.4
2-Sided
95
-51.2
-23.8
Other
The 95% CI was calculated by the method of Miettinen and Nurminen.
Week 24 Post-switch minus Time of switch
OG001
Combined Treatment Groups: Week 24 Post-Switch
Immediate Switch to MK-1439A: Participants on a baseline regimen of ATRIPLA™ for at least 12 weeks prior to screening will be switched to blinded MK-1439A orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for an additional 12 weeks.
Deferred Switch to MK-1439A: Participants will continue on their ongoing ATRIPLA™ regimen orally, once daily for 12 weeks, followed by open-label MK-1439A orally, once daily for 24 weeks.
Units
Counts
Participants
OG00086
OG00186
Title
Denominators
Categories
Title
Measurements
OG00024.2(20.5 to 27.9)
OG00110.7(8.7 to 12.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change from time of switch to 24 weeks post-switch: Treatment difference in score
Mean Difference (Final Values)
-13.4
2-Sided
95
-16.8
-10.1
Other
The 95% CI was based on a t-distribution.
Week 24 Post-switch minus Time of switch
OG00037
OG00141
Title
Denominators
Categories
LDL Cholesterol
ParticipantsOG00036
ParticipantsOG00141
Title
Measurements
OG000-10.78± 15.85
OG001-1.88± 14.88
Non-HDL Cholesterol
ParticipantsOG00037
ParticipantsOG00141
Title
Measurements
OG000-14.08± 17.17
OG001
Cholesterol
ParticipantsOG00037
ParticipantsOG00141
Title
Measurements
OG000-22.14± 19.49
OG001
HDL Cholesterol
ParticipantsOG00037
ParticipantsOG00141
Title
Measurements
OG000-8.05± 7.74
OG001
Triglyceride
ParticipantsOG00037
ParticipantsOG00141
Title
Measurements
OG000-21.19± 43.37
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference Estimate: LDL Cholesterol
Difference Estimate
-9.02
2-Sided
95
-15.69
-2.35
Other
The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment
ISG minus DSG
OG000
OG001
Difference Estimate: Non-HDL Cholesterol
Difference Estimate
-13.57
2-Sided
95
-20.79
-6.35
Other
The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment
ISG minus DSG
OG000
OG001
Difference Estimate: Cholesterol
Difference Estimate
-21.42
2-Sided
95
-29.63
-13.21
Other
The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment
ISG minus DSG
OG000
OG001
Difference Estimate: HDL Cholesterol
Difference Estimate
-8.18
2-Sided
95
-11.76
-4.60
Other
The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment
ISG minus DSG
OG000
OG001
Difference Estimate: Triglyceride
Difference Estimate
-22.18
2-Sided
95
-38.52
-5.84
Other
The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment