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Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)

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ClinicalTrials.gov Identifier: NCT02652260
Recruitment Status : Active, not recruiting
First Posted : January 11, 2016
Results First Posted : August 29, 2019
Last Update Posted : August 29, 2019
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
Conditions HIV-1
Central Nervous System
Interventions Drug: MK-1439A - Blinded
Drug: MK-1439A - Open-Label
Drug: ATRIPLA^TM
Drug: Placebo to ATRIPLA™
Drug: Placebo to MK-1439A
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 43 43
Completed 43 41
Not Completed 0 2
Reason Not Completed
Pregnancy             0             1
Withdrawal by Subject             0             1
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 43 43 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 43 participants 86 participants
41.8  (11.9) 41.6  (11.2) 41.7  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
Female
19
  44.2%
17
  39.5%
36
  41.9%
Male
24
  55.8%
26
  60.5%
50
  58.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
Hispanic or Latino
4
   9.3%
1
   2.3%
5
   5.8%
Not Hispanic or Latino
39
  90.7%
42
  97.7%
81
  94.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   7.0%
1
   2.3%
4
   4.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
25
  58.1%
23
  53.5%
48
  55.8%
White
12
  27.9%
19
  44.2%
31
  36.0%
More than one race
3
   7.0%
0
   0.0%
3
   3.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
CNS Toxicity Percentage Of Maximum Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of maximum score
Number Analyzed 43 participants 43 participants 86 participants
32.9  (16.5) 37.1  (19.0) 35.0  (17.8)
[1]
Measure Description: 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.
Fasting Lipids   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
LDL Cholesterol Number Analyzed 36 participants 41 participants 77 participants
98.67  (35.28) 99.54  (33.57) 99.13  (34.15)
Non-HDL Cholesterol Number Analyzed 37 participants 41 participants 78 participants
118.73  (36.93) 117.76  (37.83) 118.22  (37.16)
Cholesterol Number Analyzed 37 participants 41 participants 78 participants
178.11  (36.39) 173.02  (36.62) 175.44  (36.37)
HDL Cholesterol Number Analyzed 37 participants 41 participants 78 participants
59.38  (14.58) 55.27  (14.00) 57.22  (14.34)
Triglyceride Number Analyzed 37 participants 41 participants 78 participants
107.49  (65.64) 91.39  (39.43) 99.03  (53.73)
[1]
Measure Description: Mean concentrations of low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride.
[2]
Measure Analysis Population Description: All randomized participants who received at least one dose of study treatment.
1.Primary Outcome
Title Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: Percentage of participants
41.9 37.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Switch to MK-1439A, Deferred Switch to MK-1439A
Comments Treatment Difference: Immediate Switch minus Delayed Switch
Type of Statistical Test Other
Comments 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.
Statistical Test of Hypothesis P-Value 0.331
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Difference
Estimated Value 4.65
Confidence Interval (2-Sided) 95%
-15.92 to 24.85
Estimation Comments [Not Specified]
Other Statistical Analysis The 95% confidence interval (CI) was calculated by the method of Miettinen and Nurminen.
2.Secondary Outcome
Title Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4
Hide Description 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.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 43
Measure Type: Number
Unit of Measure: Percentage of participants
46.5 65.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Switch to MK-1439A, Deferred Switch to MK-1439A
Comments Treatment Difference: Immediate Switch minus Delayed Switch
Type of Statistical Test Other
Comments 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.
Method of Estimation Estimation Parameter Estimated Difference
Estimated Value -18.61
Confidence Interval (2-Sided) 95%
-38.14 to 2.51
Estimation Comments [Not Specified]
Other Statistical Analysis The 95% CI was calculated by the method of Miettinen and Nurminen.
3.Secondary Outcome
Title Change From Baseline in CNS Toxicity Score at Week 4
Hide Description 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.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 43
Mean (95% Confidence Interval)
Unit of Measure: Percentage of maximum score
-17.6
(-23.4 to -11.8)
-15.6
(-22.0 to -9.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Switch to MK-1439A, Deferred Switch to MK-1439A
Comments Treatment Difference: Immediate Switch minus Delayed Switch
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-10.5 to 6.5
Estimation Comments [Not Specified]
Other Statistical Analysis The 95% CI was based on a t-distribution.
4.Secondary Outcome
Title Change From Baseline in CNS Toxicity Score at Week 12
Hide Description 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.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 43
Mean (95% Confidence Interval)
Unit of Measure: Percentage of maximum score
-18.1
(-22.9 to -13.3)
-21.7
(-27.9 to -15.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Switch to MK-1439A, Deferred Switch to MK-1439A
Comments Treatment Difference: Immediate Switch minus Delayed Switch
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Difference
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
-4.1 to 11.3
Estimation Comments [Not Specified]
Other Statistical Analysis The 95% CI was calculated by the method of Miettinen and Nurminen.
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline (time of switch) and 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups: Time of Switch Combined Treatment Groups: Week 24 Post-Switch
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 86 86
Measure Type: Number
Unit of Measure: Percentage of participants
68.6 30.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Treatment Groups: Time of Switch, Combined Treatment Groups: Week 24 Post-Switch
Comments Change from time of switch to 24 weeks post-switch: Treatment difference in percent response
Type of Statistical Test Other
Comments The 95% CI was calculated by the method of Miettinen and Nurminen.
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -38.4
Confidence Interval (2-Sided) 95%
-51.2 to -23.8
Estimation Comments [Not Specified]
Other Statistical Analysis Week 24 Post-switch minus Time of switch
6.Secondary Outcome
Title CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups
Hide Description 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.
Time Frame Baseline (time of switch) and 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups: Time of Switch Combined Treatment Groups: Week 24 Post-Switch
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 86 86
Mean (95% Confidence Interval)
Unit of Measure: Percentage of maximum score
24.2
(20.5 to 27.9)
10.7
(8.7 to 12.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Combined Treatment Groups: Time of Switch, Combined Treatment Groups: Week 24 Post-Switch
Comments Change from time of switch to 24 weeks post-switch: Treatment difference in score
Type of Statistical Test Other
Comments The 95% CI was based on a t-distribution.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.4
Confidence Interval (2-Sided) 95%
-16.8 to -10.1
Estimation Comments [Not Specified]
Other Statistical Analysis Week 24 Post-switch minus Time of switch
7.Secondary Outcome
Title Change From Baseline in Fasting Lipids at Week 12
Hide Description 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.
Time Frame Baseline (study Day 1) and study week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment, and have required lipid data.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 37 41
Mean (Standard Deviation)
Unit of Measure: mg/dL
LDL Cholesterol Number Analyzed 36 participants 41 participants
-10.78  (15.85) -1.88  (14.88)
Non-HDL Cholesterol Number Analyzed 37 participants 41 participants
-14.08  (17.17) -0.37  (16.51)
Cholesterol Number Analyzed 37 participants 41 participants
-22.14  (19.49) 0.00  (18.04)
HDL Cholesterol Number Analyzed 37 participants 41 participants
-8.05  (7.74) 0.37  (7.91)
Triglyceride Number Analyzed 37 participants 41 participants
-21.19  (43.37) 7.10  (38.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate Switch to MK-1439A, Deferred Switch to MK-1439A
Comments Difference Estimate: LDL Cholesterol
Type of Statistical Test Other
Comments 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
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value -9.02
Confidence Interval (2-Sided) 95%
-15.69 to -2.35
Estimation Comments [Not Specified]
Other Statistical Analysis ISG minus DSG
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Immediate Switch to MK-1439A, Deferred Switch to MK-1439A
Comments Difference Estimate: Non-HDL Cholesterol
Type of Statistical Test Other
Comments 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
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value -13.57
Confidence Interval (2-Sided) 95%
-20.79 to -6.35
Estimation Comments [Not Specified]
Other Statistical Analysis ISG minus DSG
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Immediate Switch to MK-1439A, Deferred Switch to MK-1439A
Comments Difference Estimate: Cholesterol
Type of Statistical Test Other
Comments 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
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value -21.42
Confidence Interval (2-Sided) 95%
-29.63 to -13.21
Estimation Comments [Not Specified]
Other Statistical Analysis ISG minus DSG
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Immediate Switch to MK-1439A, Deferred Switch to MK-1439A
Comments Difference Estimate: HDL Cholesterol
Type of Statistical Test Other
Comments 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
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value -8.18
Confidence Interval (2-Sided) 95%
-11.76 to -4.60
Estimation Comments [Not Specified]
Other Statistical Analysis ISG minus DSG
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Immediate Switch to MK-1439A, Deferred Switch to MK-1439A
Comments Difference Estimate: Triglyceride
Type of Statistical Test Other
Comments 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
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value -22.18
Confidence Interval (2-Sided) 95%
-38.52 to -5.84
Estimation Comments [Not Specified]
Other Statistical Analysis ISG minus DSG
8.Secondary Outcome
Title Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups
Hide Description 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.
Time Frame Baseline (time of switch) and 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 76
Mean (Standard Deviation)
Unit of Measure: mg/dL
LDL Cholesterol Number Analyzed 75 participants
-10.97  (17.15)
Non-HDL Cholesterol Number Analyzed 76 participants
-13.18  (19.82)
Cholesterol Number Analyzed 76 participants
-20.91  (20.19)
HDL Cholesterol Number Analyzed 76 participants
-7.72  (9.53)
Triglyceride Number Analyzed 76 participants
-12.99  (46.61)
9.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups
Hide Description 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.
Time Frame 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 85
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
< 50 copies/mL
95.3
(88.4 to 98.7)
< 40 copies/mL
95.3
(88.4 to 98.7)
10.Secondary Outcome
Title Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups
Hide Description 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.
Time Frame Baseline (time of switch) and 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 85
Mean (95% Confidence Interval)
Unit of Measure: cells/mm^3
70.4
(35.9 to 104.8)
11.Secondary Outcome
Title Number of Participants With One or More Adverse Events (AEs) Through Study Week 12
Hide Description 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.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
34
  79.1%
34
  79.1%
12.Secondary Outcome
Title Number of Participants With One or More Drug-related AEs Through Study Week 12
Hide Description 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.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
14
  32.6%
9
  20.9%
13.Secondary Outcome
Title Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12
Hide Description 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.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With One or More Drug-related SAEs Through Study Week 12
Hide Description 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.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12
Hide Description 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.
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study treatment.
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch
Hide Description 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.
Time Frame 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 85
Measure Type: Count of Participants
Unit of Measure: Participants
71
  83.5%
17.Secondary Outcome
Title Number of Participants With One or More Drug-related AEs for the Combined Treatment Groups 24 Weeks After the Switch
Hide Description 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.
Time Frame 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 85
Measure Type: Count of Participants
Unit of Measure: Participants
18
  21.2%
18.Secondary Outcome
Title Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch
Hide Description 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.
Time Frame 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 85
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.2%
19.Secondary Outcome
Title Number of Participants With One or More Drug-related SAEs for the Combined Treatment Groups 24 Weeks After the Switch
Hide Description 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.
Time Frame 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 85
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
20.Secondary Outcome
Title Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch
Hide Description 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.
Time Frame 24 weeks post-switch
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Combined Treatment Groups
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 85
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame 14 days following the end of treatment: Immediate Switch up to 26 weeks; Delayed Switch up to 38 weeks
Adverse Event Reporting Description All randomized participants who received at least one dose of study treatment.
 
Arm/Group Title Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)      0/43 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/43 (4.65%)      2/43 (4.65%)    
Gastrointestinal disorders     
Abdominal hernia  1  1/43 (2.33%)  1 0/43 (0.00%)  0
Infections and infestations     
Pneumonia haemophilus  1  0/43 (0.00%)  0 1/43 (2.33%)  1
Injury, poisoning and procedural complications     
Spinal compression fracture  1  0/43 (0.00%)  0 1/43 (2.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  1/43 (2.33%)  1 0/43 (0.00%)  0
Psychiatric disorders     
Conversion disorder  1  1/43 (2.33%)  1 0/43 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
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%
Immediate Switch to MK-1439A Deferred Switch to MK-1439A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/43 (76.74%)      36/43 (83.72%)    
Gastrointestinal disorders     
Diarrhoea  1  6/43 (13.95%)  7 7/43 (16.28%)  9
Nausea  1  5/43 (11.63%)  6 2/43 (4.65%)  2
Vomiting  1  2/43 (4.65%)  3 4/43 (9.30%)  4
General disorders     
Influenza like illness  1  3/43 (6.98%)  3 1/43 (2.33%)  1
Infections and infestations     
Conjunctivitis  1  1/43 (2.33%)  1 4/43 (9.30%)  4
Gastroenteritis  1  3/43 (6.98%)  3 0/43 (0.00%)  0
Lower respiratory tract infection  1  3/43 (6.98%)  3 1/43 (2.33%)  2
Nasopharyngitis  1  5/43 (11.63%)  6 3/43 (6.98%)  6
Rhinitis  1  3/43 (6.98%)  3 1/43 (2.33%)  1
Upper respiratory tract infection  1  7/43 (16.28%)  9 12/43 (27.91%)  14
Viral upper respiratory tract infection  1  1/43 (2.33%)  1 3/43 (6.98%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/43 (16.28%)  10 3/43 (6.98%)  4
Back pain  1  6/43 (13.95%)  7 3/43 (6.98%)  3
Nervous system disorders     
Disturbance in attention  1  5/43 (11.63%)  5 9/43 (20.93%)  9
Dizziness  1  9/43 (20.93%)  9 8/43 (18.60%)  10
Headache  1  13/43 (30.23%)  17 10/43 (23.26%)  14
Somnolence  1  7/43 (16.28%)  8 10/43 (23.26%)  10
Psychiatric disorders     
Abnormal dreams  1  6/43 (13.95%)  6 8/43 (18.60%)  8
Aggression  1  4/43 (9.30%)  5 5/43 (11.63%)  5
Anxiety  1  5/43 (11.63%)  6 9/43 (20.93%)  11
Confusional state  1  3/43 (6.98%)  3 4/43 (9.30%)  4
Depressed mood  1  5/43 (11.63%)  5 3/43 (6.98%)  3
Depression  1  7/43 (16.28%)  7 4/43 (9.30%)  5
Insomnia  1  8/43 (18.60%)  9 13/43 (30.23%)  18
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/43 (6.98%)  3 3/43 (6.98%)  3
Oropharyngeal pain  1  3/43 (6.98%)  4 3/43 (6.98%)  3
Productive cough  1  2/43 (4.65%)  2 3/43 (6.98%)  3
Skin and subcutaneous tissue disorders     
Night sweats  1  1/43 (2.33%)  1 3/43 (6.98%)  3
Pruritus  1  3/43 (6.98%)  4 2/43 (4.65%)  2
1
Term from vocabulary, MedDRA 21.0
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. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02652260     History of Changes
Other Study ID Numbers: 1439A-028
2015-003617-18 ( EudraCT Number )
MK-1439A-028 ( Other Identifier: Merck Protocol Number )
First Submitted: January 8, 2016
First Posted: January 11, 2016
Results First Submitted: July 16, 2019
Results First Posted: August 29, 2019
Last Update Posted: August 29, 2019