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 : September 27, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme LLC

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: Doravirine, Tenofovir, Lamivudine - Blinded Drug: Doravirine, Tenofovir, Lamivudine - Open-Label Drug: ATRIPLA^TM Drug: Placebo to ATRIPLA™ Drug: Placebo to Doravirine, Tenofovir, Lamivudine
Enrollment	86

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Immediate Switch to MK-1439A	Deferred Switch to MK-1439A
Arm/Group Description	Participants on a baseline regimen ...	Participants will continue on their...
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

Baseline Characteristics

Arm/Group Title		Immediate Switch to MK-1439A	Deferred Switch to MK-1439A	Total
Arm/Group Description		Participants on a baseline regimen ...	Participants will continue on their...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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
LDL Cholesterol		98.67 (35.28)	99.54 (33.57)	99.13 (34.15)
Non-HDL Cholesterol	Number Analyzed	37 participants	41 participants	78 participants
Non-HDL Cholesterol		118.73 (36.93)	117.76 (37.83)	118.22 (37.16)
Cholesterol	Number Analyzed	37 participants	41 participants	78 participants
Cholesterol		178.11 (36.39)	173.02 (36.62)	175.44 (36.37)
HDL Cholesterol	Number Analyzed	37 participants	41 participants	78 participants
HDL Cholesterol		59.38 (14.58)	55.27 (14.00)	57.22 (14.34)
Triglyceride	Number Analyzed	37 participants	41 participants	78 participants
Triglyceride		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.

Outcome Measures

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
Description	A questionnaire was used to solicit for CNS toxicity based on the foll...
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

Outcome Measure Data

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
Arm/Group Description:	Participants on a baseline regimen ...	Participants will continue on their...
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

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
Description	A questionnaire was used to solicit for CNS toxicity based on the foll...
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

Outcome Measure Data

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
Arm/Group Description:	Participants on a baseline regimen ...	Participants will continue on their...
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

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
Description	A questionnaire was used to solicit for CNS toxicity based on the foll...
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

Outcome Measure Data

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
Arm/Group Description:	Participants on a baseline regimen ...	Participants will continue on their...
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)

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
Description	A questionnaire was used to solicit for CNS toxicity based on the foll...
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

Outcome Measure Data

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
Arm/Group Description:	Participants on a baseline regimen ...	Participants will continue on their...
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)

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
Description	A questionnaire was used to solicit for CNS toxicity based on the foll...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Combined Treatment Groups: Time of Switch	Combined Treatment Groups: Week 24 Post-Switch
Arm/Group Description:	Immediate Switch to MK-1439A: Parti...	Immediate Switch to MK-1439A: Parti...
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

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
Description	A questionnaire was used to solicit for CNS toxicity based on the foll...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Combined Treatment Groups: Time of Switch	Combined Treatment Groups: Week 24 Post-Switch
Arm/Group Description:	Immediate Switch to MK-1439A: Parti...	Immediate Switch to MK-1439A: Parti...
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)

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
Description	Blood was collected under fasting conditions on Day 1 and on week 12 i...
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

Outcome Measure Data

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
Arm/Group Description:		Participants on a baseline regimen ...	Participants will continue on their...
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
LDL Cholesterol		-10.78 (15.85)	-1.88 (14.88)
Non-HDL Cholesterol	Number Analyzed	37 participants	41 participants
Non-HDL Cholesterol		-14.08 (17.17)	-0.37 (16.51)
Cholesterol	Number Analyzed	37 participants	41 participants
Cholesterol		-22.14 (19.49)	0.00 (18.04)
HDL Cholesterol	Number Analyzed	37 participants	41 participants
HDL Cholesterol		-8.05 (7.74)	0.37 (7.91)
Triglyceride	Number Analyzed	37 participants	41 participants
Triglyceride		-21.19 (43.37)	7.10 (38.55)

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

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

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

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

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
Description	Blood was collected under fasting conditions at time of switch and 24 ...
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

Outcome Measure Data

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
Arm/Group Description:		Immediate Switch to MK-1439A: Parti...
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
LDL Cholesterol		-10.97 (17.15)
Non-HDL Cholesterol	Number Analyzed	76 participants
Non-HDL Cholesterol		-13.18 (19.82)
Cholesterol	Number Analyzed	76 participants
Cholesterol		-20.91 (20.19)
HDL Cholesterol	Number Analyzed	76 participants
HDL Cholesterol		-7.72 (9.53)
Triglyceride	Number Analyzed	76 participants
Triglyceride		-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
Description	Blood was collected under fasting conditions at 24 weeks post-switch i...
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

Outcome Measure Data

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
Arm/Group Description:	Immediate Switch to MK-1439A: Parti...
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
Description	Blood was collected at time of switch and at 24 weeks post-switch in o...
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

Outcome Measure Data

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
Arm/Group Description:	Immediate Switch to MK-1439A: Parti...
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
Description	An adverse event (AE) is any untoward medical occurrence in a particip...
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

Outcome Measure Data

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
Arm/Group Description:	Participants on a baseline regimen ...	Participants will continue on their...
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
Description	An adverse event (AE) is any untoward medical occurrence in a particip...
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

Outcome Measure Data

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
Arm/Group Description:	Participants on a baseline regimen ...	Participants will continue on their...
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
Description	A serious adverse event (SAE) is any AE occurring at any dose or durin...
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

Outcome Measure Data

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
Arm/Group Description:	Participants on a baseline regimen ...	Participants will continue on their...
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
Description	A serious adverse event (SAE) is any AE occurring at any dose or durin...
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

Outcome Measure Data

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
Arm/Group Description:	Participants on a baseline regimen ...	Participants will continue on their...
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
Description	An AE is any untoward medical occurrence in a participant administered...
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

Outcome Measure Data

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
Arm/Group Description:	Participants on a baseline regimen ...	Participants will continue on their...
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
Description	An AE is any untoward medical occurrence in a participant administered...
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

Outcome Measure Data

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
Arm/Group Description:	Immediate Switch to MK-1439A: Parti...
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
Description	An AE is any untoward medical occurrence in a participant administered...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Combined Treatment Groups
Arm/Group Description:	Immediate Switch to MK-1439A: Parti...
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
Description	A serious adverse event (SAE) is any AE occurring at any dose or durin...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Combined Treatment Groups
Arm/Group Description:	Immediate Switch to MK-1439A: Parti...
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
Description	A serious adverse event (SAE) is any AE occurring at any dose or durin...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Combined Treatment Groups
Arm/Group Description:	Immediate Switch to MK-1439A: Parti...
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
Description	An AE is any untoward medical occurrence in a participant administered...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Combined Treatment Groups
Arm/Group Description:	Immediate Switch to MK-1439A: Parti...
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%

Adverse Events

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
Arm/Group Description	Participants on a baseline regimen ...		Participants will continue on their...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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 LLC
Phone:	1-800-672-6372
EMail:	ClinicalTrialsDisclosure@merck.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nelson M, Winston A, Hill A, Mngqibisa R, Bassa A, Orkin C, Rassool M, Rodgers A, Teal V, Kumar S, Teppler H. Efficacy, safety and central nervous system effects after switch from efavirenz/tenofovir/emtricitabine to doravirine/tenofovir/lamivudine. AIDS. 2021 Apr 1;35(5):759-767. doi: 10.1097/QAD.0000000000002804.

Layout table for additonal information

Responsible Party:	Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:	NCT02652260
Other Study ID Numbers:	1439A-028 MK-1439A-028 ( Other Identifier: Merck Protocol Number ) 2015-003617-18 ( EudraCT 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:	September 27, 2022

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