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

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ClinicalTrials.gov Identifier: NCT02403674
Recruitment Status : Active, not recruiting
First Posted : March 31, 2015
Results First Posted : April 30, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus (HIV)
Interventions Drug: MK-1439A
Drug: ATRIPLA™
Drug: Placebo
Enrollment 734

Recruitment Details Treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection have been recruited at 126 study sites worldwide. The present results are based on the first 48 weeks of this ongoing 96-week study.
Pre-assignment Details  
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet fixed dose combination (FDC) containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, once daily (q.d.) by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding. Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Period Title: Overall Study
Started [1] 368 366
Treated [2] 364 364
Completed [3] 313 303
Not Completed 55 63
Reason Not Completed
Adverse Event             10             23
Death             1             3
Lack of Efficacy             18             10
Lost to Follow-up             6             7
Noncompliance with study drug             1             2
Withdrawal by Subject             8             11
Physician Decision             2             2
Not treated with study drug             4             2
Pregnancy             1             1
Protocol Violation             4             2
[1]
Randomized
[2]
Received ≥1 dose of study medication.
[3]
Completed through Week 48 and ongoing in study
Arm/Group Title MK-1439A ATRIPLA™ Total
Hide Arm/Group Description Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding. Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding. Total of all reporting groups
Overall Number of Baseline Participants 364 364 728
Hide Baseline Analysis Population Description
The Baseline Analysis Population consists of all randomized participants who received ≥1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 364 participants 364 participants 728 participants
33.6  (10.5) 32.7  (9.9) 33.1  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 364 participants 728 participants
Female
59
  16.2%
53
  14.6%
112
  15.4%
Male
305
  83.8%
311
  85.4%
616
  84.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 364 participants 364 participants 728 participants
American Indian or Alaska Native
10
   2.7%
6
   1.6%
16
   2.2%
Asian
59
  16.2%
65
  17.9%
124
  17.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
67
  18.4%
68
  18.7%
135
  18.5%
White
177
  48.6%
170
  46.7%
347
  47.7%
More than one race
51
  14.0%
55
  15.1%
106
  14.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Baseline cluster of differentiation 4 (CD4) cell counts  
Mean (Standard Deviation)
Unit of measure:  Cells/mm^3
Number Analyzed 364 participants 364 participants 728 participants
434.9  (217.9) 415.5  (210.6) 425.2  (214.3)
Baseline fasting low-density lipoprotein cholesterol (LDL-C)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 353 participants 352 participants 705 participants
92.08  (32.32) 90.47  (30.64) 91.27  (31.48)
[1]
Measure Description: Participants fasted for ≥8 hours prior to LDL-C measurement on Day 1.
[2]
Measure Analysis Population Description: All randomized participants with baseline data available.
Baseline fasting non-high-density lipoprotein cholesterol (non-HDL-C)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 357 participants 357 participants 714 participants
115.39  (34.67) 114.63  (33.55) 115.01  (34.09)
[1]
Measure Description: Participants fasted for ≥8 hours prior to non-HDL-C measurement on Day 1.
[2]
Measure Analysis Population Description: All randomized participants with baseline data available.
Baseline fasting cholesterol   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 357 participants 357 participants 714 participants
157.29  (36.43) 156.07  (36.51) 156.68  (36.45)
[1]
Measure Description: Participants fasted for ≥8 hours prior to cholesterol measurement on Day 1.
[2]
Measure Analysis Population Description: All randomized participants with baseline data available.
Baseline fasting triglycerides   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 357 participants 357 participants 714 participants
120.85  (83.06) 123.23  (82.73) 122.04  (82.84)
[1]
Measure Description: Participants fasted for ≥8 hour prior to triglycerides measurement on Day 1.
[2]
Measure Analysis Population Description: All randomized participants with baseline data available.
Baseline fasting high-density lipoprotein cholesterol (HDL-C)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 357 participants 357 participants 714 participants
41.90  (11.67) 41.44  (13.08) 41.67  (12.38)
[1]
Measure Description: Participants fasted for ≥8 hours prior to HDL-C measurement on Day 1.
[2]
Measure Analysis Population Description: All randomized participants with baseline data available.
1.Primary Outcome
Title Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 364 364
Measure Type: Number
Unit of Measure: Percentage of Participants
84.3 80.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 3.537
Confidence Interval (2-Sided) 95%
-1.951 to 9.026
Estimation Comments The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or >100,000 copies/mL).
2.Primary Outcome
Title Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all randomized participants who received ≥1 dose of study medication.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 364 364
Measure Type: Number
Unit of Measure: Percentage of Participants
Dizziness 8.8 37.1
Sleep disorders and disturbances 12.1 25.5
Altered sensorium 4.4 8.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments Dizziness difference
Type of Statistical Test Superiority
Comments Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
Statistical Test of Hypothesis P-Value <0.001
Comments 2-sided P-value
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -28.3
Confidence Interval (2-Sided) 95%
-34.0 to -22.5
Estimation Comments 95% CIs were calculated using the Miettinen and Nurminen method.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments Sleep disorders and disturbances difference
Type of Statistical Test Superiority
Comments Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
Statistical Test of Hypothesis P-Value <0.001
Comments 2-sided P-value
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -13.5
Confidence Interval (2-Sided) 95%
-19.1 to -7.9
Estimation Comments 95% CIs were calculated using the Miettinen and Nurminen method.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments Altered sensorium difference
Type of Statistical Test Superiority
Comments Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
Statistical Test of Hypothesis P-Value 0.033
Comments 2-sided P-value
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-7.6 to -0.3
Estimation Comments 95% CIs were calculated using the Miettinen and Nurminen method.
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 364 364
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
83.8
(79.6 to 87.4)
79.7
(75.2 to 83.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value 4.1
Confidence Interval (2-Sided) 95%
-1.5 to 9.7
Estimation Comments The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or >100,000 copies/mL).
5.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in CD4 Cell Counts at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline and Week 48 CD4 data available.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 344 329
Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
198.4
(180.2 to 216.7)
188.4
(169.5 to 207.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Superiority was declared when group difference (MK-1439A-ATRIPLA®) was a positive value.
Method of Estimation Estimation Parameter Difference in mean %change from baseline
Estimated Value 10.1
Confidence Interval (2-Sided) 95%
-16.1 to 36.3
Estimation Comments 95% CIs were calculated based on t-distribution.
7.Secondary Outcome
Title Change From Baseline in CD4 Cell Counts at Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline CD4 data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Percentage of Participants Experiencing ≥1 AE
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received ≥1 dose of study medication.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 364 364
Measure Type: Number
Unit of Measure: Percentage of participants
82.7 90.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference in percentage of participants with ≥1 AE(s)
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -8.0
Confidence Interval (2-Sided) 95%
-13.0 to -3.1
Estimation Comments 95% CIs were calculated with the Miettinen & Nurminen method.
9.Secondary Outcome
Title Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received ≥1 dose of study medication.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 364 364
Measure Type: Number
Unit of Measure: Percentage of participants
3.0 6.6
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Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Other
Comments Difference in percentage of participants with ≥1 AE(s)
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -3.6
Confidence Interval (2-Sided) 95%
-6.9 to -0.5
Estimation Comments 95% CIs were calculated with the Miettinen & Nurminen method.
10.Secondary Outcome
Title Percentage of Participants With Tier-2 Neuropsychiatric AEs
Hide 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
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Hide Analysis Population Description
The analysis population consists of all randomized participants who received ≥1 dose of study medication.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 364 364
Measure Type: Number
Unit of Measure: Percentage of Participants
Depression and suicide/self-injury 4.1 6.6
Psychosis and psychotic disorders 0.3 1.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments Depression and suicide/self-injury difference
Type of Statistical Test Superiority
Comments Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
Statistical Test of Hypothesis P-Value <0.001
Comments 2-sided P-value
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-5.9 to 0.8
Estimation Comments 95% CIs were calculated using the Miettinen and Nurminen method.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments Psychosis and psychotic disorders difference
Type of Statistical Test Superiority
Comments Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.
Statistical Test of Hypothesis P-Value <0.001
Comments 2-sided P-value
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-2.5 to 0.5
Estimation Comments 95% CIs were calculated using the Miettinen and Nurminen method.
11.Secondary Outcome
Title Change From Baseline in Fasting LDL-C at Week 48
Hide 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
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Hide Analysis Population Description
The analysis population consists of all randomized participants who had baseline LDL-C data available as well as ≥1 LDL-C measurement after initiating study treatment.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 330 305
Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
-1.58
(-3.98 to 0.81)
8.74
(5.86 to 11.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in mean %change from baseline
Estimated Value -10.01
Confidence Interval (2-Sided) 95%
-13.53 to -6.49
Estimation Comments 95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.
12.Secondary Outcome
Title Change From Baseline in Fasting Non-HDL-C at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all randomized participants who had baseline non-HDL-C data available as well as ≥1 non-HDL-C measurement after initiating study treatment.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 333 314
Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
-3.83
(-6.27 to -1.40)
13.26
(10.07 to 16.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in mean %change from baseline
Estimated Value -17.02
Confidence Interval (2-Sided) 95%
-20.89 to -13.16
Estimation Comments 95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.
13.Secondary Outcome
Title Change From Baseline in Fasting Cholesterol at Week 48
Hide 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
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Hide Analysis Population Description
The analysis population consists of all randomized participants who had baseline cholesterol data available as well as ≥1 cholesterol measurement after initiating study treatment.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 333 314
Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
-1.97
(-4.74 to 0.79)
21.77
(18.35 to 25.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in mean %change from baseline
Estimated Value -23.44
Confidence Interval (2-Sided) 95%
-27.57 to -19.32
Estimation Comments 95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.
14.Secondary Outcome
Title Change From Baseline in Fasting Triglycerides at Week 48
Hide 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
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Hide Analysis Population Description
The analysis population consists of all randomized participants who had baseline triglyceride data available as well as ≥1 triglyceride measurement after initiating study treatment.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 333 314
Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
-12.40
(-19.66 to -5.15)
22.01
(11.68 to 32.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in mean %change from baseline
Estimated Value -35.96
Confidence Interval (2-Sided) 95%
-47.10 to -24.82
Estimation Comments 95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.
15.Secondary Outcome
Title Change From Baseline in Fasting HDL-C at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all randomized participants who had baseline HDL-C data available as well as ≥1 HDL-C measurement after initiating study treatment.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 333 314
Mean (95% Confidence Interval)
Unit of Measure: Percent Change from Baseline
1.86
(0.83 to 2.89)
8.51
(7.32 to 9.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MK-1439A, ATRIPLA™
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in mean %change from baseline
Estimated Value -6.47
Confidence Interval (2-Sided) 95%
-7.97 to -4.96
Estimation Comments 95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.
16.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 364 364
Measure Type: Number
Unit of Measure: Percentage of Participants
59.6 55.5
17.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA BLoQ at Week 96
Hide 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
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Hide Analysis Population Description
The analysis population will consist of all randomized participants who receive ≥1 dose of study medication and have baseline HIV-1 RNA data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.
Arm/Group Title MK-1439A ATRIPLA™
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Plasma Concentration of Doravirine at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all randomized participants in the MK-1439A arm who received ≥1 dose of study drug and had doravirine concentration data available.
Arm/Group Title MK-1439A
Hide Arm/Group Description:
Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
Overall Number of Participants Analyzed 312
Mean (Standard Deviation)
Unit of Measure: nM
Pre-dose Number Analyzed 312 participants
1290  (799)
0.5 to 2 hours post-dose Number Analyzed 310 participants
2330  (1230)
Time Frame Up to 48 weeks
Adverse Event Reporting 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. All participants who received ≥1 dose of study drug are included.
 
Arm/Group Title MK-1439A (DOR+LAM+TEN) ATRIPLA (EFA+EMT+TEN)
Hide Arm/Group Description Treatment-naive participants with HIV-1 infection took MK-1439A, a single-tablet FDC containing doravirine 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, q.d. by mouth for 48 weeks (and will take MK-1439A for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to ATRIPLA™ q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding. Treatment-naive participants with HIV-1 infection took 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 48 weeks (and will take ATRIPLA for an additional 48 weeks for a total of 96 weeks). Participants also took 1 placebo tablet matched to MK-1439A q.d. by mouth for 48 weeks (and will take placebo for an additional 48 weeks for a total of 96 weeks) in order to maintain blinding.
All-Cause Mortality
MK-1439A (DOR+LAM+TEN) ATRIPLA (EFA+EMT+TEN)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/364 (0.00%)      2/364 (0.55%)    
Show Serious Adverse Events Hide Serious Adverse Events
MK-1439A (DOR+LAM+TEN) ATRIPLA (EFA+EMT+TEN)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/364 (3.57%)      21/364 (5.77%)    
Blood and lymphatic system disorders     
Normochromic normocytic anaemia  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Cardiac disorders     
Supraventricular tachycardia  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Gastrointestinal disorders     
Colitis  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Oesophageal obstruction  1  1/364 (0.27%)  1 0/364 (0.00%)  0
General disorders     
Asthenia  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Death  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Hepatobiliary disorders     
Bile duct stone  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Infections and infestations     
Appendicitis  1  1/364 (0.27%)  1 1/364 (0.27%)  1
Clostridium difficile infection  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Endometritis  1  1/364 (0.27%)  1 1/364 (0.27%)  1
Gastrointestinal viral infection  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Nasopharyngitis  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Oophoritis  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Oral bacterial infection  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Pilonidal cyst  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Pneumonia  1  1/364 (0.27%)  1 1/364 (0.27%)  1
Pneumonia bacterial  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Sepsis  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Subcutaneous abscess  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Viral infection  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Injury, poisoning and procedural complications     
Alcohol poisoning  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Post procedural haemorrhage  1  1/364 (0.27%)  2 0/364 (0.00%)  0
Subdural haematoma  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Traumatic haemothorax  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Metabolism and nutrition disorders     
Hypertriglyceridaemia  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Anal squamous cell carcinoma  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Anogenital warts  1  2/364 (0.55%)  4 0/364 (0.00%)  0
Basal cell carcinoma  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Squamous cell carcinoma of the tongue  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Nervous system disorders     
Syncope  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Psychiatric disorders     
Completed suicide  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Insomnia  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Nightmare  1  1/364 (0.27%)  1 0/364 (0.00%)  0
Suicide attempt  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Skin and subcutaneous tissue disorders     
Rash generalised  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Rash macular  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Rash maculo-papular  1  0/364 (0.00%)  0 1/364 (0.27%)  1
Vascular disorders     
Malignant hypertension  1  0/364 (0.00%)  0 1/364 (0.27%)  1
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-1439A (DOR+LAM+TEN) ATRIPLA (EFA+EMT+TEN)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   184/364 (50.55%)      263/364 (72.25%)    
Gastrointestinal disorders     
Diarrhoea  1  39/364 (10.71%)  59 49/364 (13.46%)  55
Nausea  1  28/364 (7.69%)  31 39/364 (10.71%)  46
Vomiting  1  15/364 (4.12%)  18 27/364 (7.42%)  33
General disorders     
Fatigue  1  21/364 (5.77%)  23 22/364 (6.04%)  24
Infections and infestations     
Nasopharyngitis  1  39/364 (10.71%)  54 31/364 (8.52%)  38
Pharyngitis  1  20/364 (5.49%)  25 15/364 (4.12%)  17
Upper respiratory tract infection  1  33/364 (9.07%)  37 23/364 (6.32%)  28
Nervous system disorders     
Dizziness  1  32/364 (8.79%)  42 135/364 (37.09%)  146
Headache  1  47/364 (12.91%)  64 45/364 (12.36%)  59
Somnolence  1  12/364 (3.30%)  12 27/364 (7.42%)  27
Psychiatric disorders     
Abnormal dreams  1  17/364 (4.67%)  18 42/364 (11.54%)  44
Insomnia  1  18/364 (4.95%)  22 32/364 (8.79%)  34
Skin and subcutaneous tissue disorders     
Rash  1  17/364 (4.67%)  19 44/364 (12.09%)  47
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02403674     History of Changes
Other Study ID Numbers: 1439A-021
2014-003382-17 ( EudraCT Number )
DRIVE-AHEAD ( Other Identifier: Merck Sharp & Dohme Corp. )
MK-1439A-021 ( Other Identifier: Merck Protocol Number )
First Submitted: March 26, 2015
First Posted: March 31, 2015
Results First Submitted: February 8, 2018
Results First Posted: April 30, 2018
Last Update Posted: May 31, 2018