Trial Outcomes & Findings for Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL) (NCT NCT00711009)

Results Overview

A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

206 participants

Primary outcome timeframe

Baseline to Week 48

Results posted on

2012-02-14

Participant Flow

3 additional participants were randomized but did not receive study drug and therefore were not included in the analyses.

Participant milestones

Participant milestones
Measure	LPV/r + FTC/TDF lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Study STARTED	105	101
Overall Study COMPLETED	90	82
Overall Study NOT COMPLETED	15	19

Reasons for withdrawal

Reasons for withdrawal
Measure	LPV/r + FTC/TDF lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Study Adverse Event/HIV-Related Event	4	5
Overall Study Withdrawal by Subject	4	2
Overall Study Lost to Follow-up	3	9
Overall Study Participant Noncompliant	0	1
Overall Study Virologic Failure	2	1
Overall Study Pregnancy	1	0
Overall Study Site closing	0	1
Overall Study Dose adjustment	1	0

Baseline Characteristics

Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LPV/r + FTC/TDF n=105 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=101 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily	Total n=206 Participants Total of all reporting groups
Age Continuous	39.4 years STANDARD_DEVIATION 11.24 • n=5 Participants	39.8 years STANDARD_DEVIATION 9.94 • n=7 Participants	39.6 years STANDARD_DEVIATION 10.60 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	13 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	88 Participants n=7 Participants	174 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	22 participants n=5 Participants	22 participants n=7 Participants	44 participants n=5 Participants
Race/Ethnicity, Customized White	81 participants n=5 Participants	74 participants n=7 Participants	155 participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment North America	61 participants n=5 Participants	59 participants n=7 Participants	120 participants n=5 Participants
Region of Enrollment Europe	44 participants n=5 Participants	42 participants n=7 Participants	86 participants n=5 Participants
Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Level	4.3 log10 copies/milliliter STANDARD_DEVIATION 0.76 • n=5 Participants	4.2 log10 copies/milliliter STANDARD_DEVIATION 0.83 • n=7 Participants	4.2 log10 copies/milliliter STANDARD_DEVIATION 0.79 • n=5 Participants
CD4+ T-Cell Counts	297.6 cells/microliter STANDARD_DEVIATION 166.66 • n=5 Participants	289.3 cells/microliter STANDARD_DEVIATION 149.03 • n=7 Participants	293.5 cells/microliter STANDARD_DEVIATION 157.93 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 48

Population: Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.

A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=105 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=101 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm	84.8 Percentage of Participants	83.2 Percentage of Participants

PRIMARY outcome

Timeframe: Week 96

Population: Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.

Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=105 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=101 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events Any adverse event	34.3 Percentage of participants	30.7 Percentage of participants
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events Diarrhoea	16.2 Percentage of participants	7.9 Percentage of participants
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events Hyperchloresterolaemia	4.8 Percentage of participants	8.9 Percentage of participants
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events Hypertriglyceridaemia	2.9 Percentage of participants	5.9 Percentage of participants
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events Hyperlipidaemia	1.0 Percentage of participants	3.0 Percentage of participants
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events Blood triglycerides increased	1.9 Percentage of participants	3.0 Percentage of participants
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events Alanine aminotransferase increased	1.0 Percentage of participants	3.0 Percentage of participants
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events Aspartate aminotransferase increased	0 Percentage of participants	2.0 Percentage of participants
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events Asthenia	2.9 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Baseline to Week 96

Population: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value.

Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=104 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=101 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Alananine aminotransferase >5x upper limit normal	2.9 Percentage of participants	5.0 Percentage of participants
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Aspartate aminotransferase >5x upper limit normal	2.9 Percentage of participants	5.0 Percentage of participants
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Creatinine phosphokinase >4x upper limit of normal	8.7 Percentage of participants	19.8 Percentage of participants
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Calcium <1.75 millimoles/liter	0 Percentage of participants	2.0 Percentage of participants
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Cholesterol >7.77 millimoles/liter	13.5 Percentage of participants	16.8 Percentage of participants
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Triglycerides >8.475 millimoles/liter	4.8 Percentage of participants	9.9 Percentage of participants
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Calc. creatinine clearance <50 milliliters/minute	3.8 Percentage of participants	1.0 Percentage of participants
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Lipase >2x upper limit of normal	7.7 Percentage of participants	4.0 Percentage of participants
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Neutrophils < 0.75 x 10^9/liter	3.8 Percentage of participants	0 Percentage of participants
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values Magnesium < 0.5 millimoles/liter	0 Percentage of participants	2.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.

A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=105 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=101 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 2	7.6 Percentage of Participants	33.7 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 4	17.1 Percentage of Participants	63.4 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 8	36.2 Percentage of Participants	75.2 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 16	67.6 Percentage of Participants	81.2 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 24	80.0 Percentage of Participants	83.2 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 32	85.7 Percentage of Participants	85.1 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 40	84.8 Percentage of Participants	87.1 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 48	84.8 Percentage of Participants	83.2 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 60	82.9 Percentage of Participants	75.2 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 72	78.1 Percentage of Participants	71.3 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 84	74.3 Percentage of Participants	70.3 Percentage of Participants
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm Week 96	68.6 Percentage of Participants	66.3 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and the visit were included in the analysis of data at that visit. Number of participants in each visit analysis ranged from 98 and 96 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 8, to 80 and 76 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 96.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=105 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=101 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 96	296.4 cells/microliter Standard Error 20.38	281.0 cells/microliter Standard Error 20.91
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 4	97.2 cells/microliter Standard Error 10.94	113.4 cells/microliter Standard Error 10.83
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 8	107.9 cells/microliter Standard Error 12.07	124.5 cells/microliter Standard Error 12.20
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 16	158.7 cells/microliter Standard Error 13.94	141.6 cells/microliter Standard Error 14.01
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 24	154.9 cells/microliter Standard Error 13.76	174.5 cells/microliter Standard Error 13.99
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 32	180.0 cells/microliter Standard Error 13.42	188.2 cells/microliter Standard Error 13.49
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 40	204.6 cells/microliter Standard Error 15.22	223.0 cells/microliter Standard Error 15.55
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 48	245.0 cells/microliter Standard Error 18.02	241.9 cells/microliter Standard Error 17.83
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 60	243.4 cells/microliter Standard Error 18.05	250.6 cells/microliter Standard Error 18.45
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 72	277.4 cells/microliter Standard Error 20.10	269.9 cells/microliter Standard Error 20.47
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit Week 84	309.6 cells/microliter Standard Error 19.83	280.2 cells/microliter Standard Error 21.05

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.

Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=105 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=101 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672	79.1 Percentage of Participants	77.8 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from \<40 copies/ml to \>=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.

Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=5 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=8 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel. Lopinavir resistance	0 Participants	0 Participants
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel. Emtricitabine resistance	1 Participants	0 Participants
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel. Tenofovir resistance	0 Participants	0 Participants
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel. Raltegravir resistance	NA Participants Participants in this treatment group did not receive raltegravir; as a result, the potential for developing resistance to raltegravir is not applicable.	3 Participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from \<40 copies/mL to \>=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.

Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=5 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=8 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=75 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=67 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey	-1.0 Scores on a scale Standard Error 1.34	-1.1 Scores on a scale Standard Error 1.51

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=75 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=67 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey	1.3 Scores on a scale Standard Error 1.44	1.3 Scores on a scale Standard Error 1.62

SECONDARY outcome

Timeframe: Week 96

Population: Participants who had values at Week 96 were included in the analysis.

The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=84 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=80 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)	75.5 Scores on a scale Standard Deviation 23.29	76.0 Scores on a scale Standard Deviation 27.47

SECONDARY outcome

Timeframe: Week 96

Population: Participants who had values at Week 96 were included in the analysis.

The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=85 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=80 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication	84.6 Scores on a scale Standard Deviation 17.56	86.2 Scores on a scale Standard Deviation 19.15

SECONDARY outcome

Timeframe: Week 96

Population: Participants who had values at Week 96 were included in the analysis.

The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=85 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=80 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication	82.5 Scores on a scale Standard Deviation 15.49	85.5 Scores on a scale Standard Deviation 15.62

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Hemoglobin (Grams/Liter)	5.4 grams/liter Standard Deviation 13.26	5.1 grams/liter Standard Deviation 13.05

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Hematocrit (Fraction)	0.038 % by volume of packed RBCs in blood Standard Deviation 0.0379	0.036 % by volume of packed RBCs in blood Standard Deviation 0.0386

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)	0.12 number of cells x 10^12/liter Standard Deviation 0.450	0.16 number of cells x 10^12/liter Standard Deviation 0.471

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Platelet Count (x 10^9/Liter)	46.8 number of cells x 10^9/liter Standard Deviation 69.18	34.2 number of cells x 10^9/liter Standard Deviation 68.94

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)	0.90 number of cells x 10^9/liter Standard Deviation 1.717	1.20 number of cells x 10^9/liter Standard Deviation 1.670

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Neutrophils (x 10^9/Liter)	0.509 number of cells x 10^9/liter Standard Deviation 1.2256	0.705 number of cells x 10^9/liter Standard Deviation 1.2836

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Lymphocytes (x 10^9/Liter)	0.332 number of cells x 10^9/liter Standard Deviation 0.6901	0.368 number of cells x 10^9/liter Standard Deviation 0.8068

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Monocytes (x 10^9/Liter)	0.065 number of cells x 10^9/liter Standard Deviation 0.1435	0.112 number of cells x 10^9/liter Standard Deviation 0.1436

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Eosinophils (x 10^9/Liter)	-0.012 number of cells x 10^9/liter Standard Deviation 0.0817	0.015 number of cells x 10^9/liter Standard Deviation 0.1063

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Basophils (x 10^9/Liter)	0.005 number of cells x 10^9/liter Standard Deviation 0.0233	0.003 number of cells x 10^9/liter Standard Deviation 0.0222

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)	-6.1 units/liter Standard Deviation 41.45	-13.4 units/liter Standard Deviation 39.96

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)	-0.8 units/liter Standard Deviation 64.29	-9.6 units/liter Standard Deviation 37.86

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)	14.5 units/liter Standard Deviation 20.26	1.7 units/liter Standard Deviation 24.53

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)	398.9 units/liter Standard Deviation 3381.10	157.2 units/liter Standard Deviation 1081.24

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)	0.9 micromoles/liter Standard Deviation 4.17	1.9 micromoles/liter Standard Deviation 6.16

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Creatinine (Micromoles/Liter)	5.7 micromoles/liter Standard Deviation 12.66	1.6 micromoles/liter Standard Deviation 11.54

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)	0.00 micromoles/liter Standard Deviation 1.390	0.37 micromoles/liter Standard Deviation 1.658

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Uric Acid (Micromoles/Liter)	-29.0 micromoles/liter Standard Deviation 65.25	-6.1 micromoles/liter Standard Deviation 66.29

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)	-0.046 micromoles/liter Standard Deviation 0.1645	-0.028 micromoles/liter Standard Deviation 0.2391

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Calcium (Micromoles/Liter)	-0.040 micromoles/liter Standard Deviation 0.1071	-0.016 micromoles/liter Standard Deviation 0.1468

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Sodium (Micromoles/Liter)	0.1 micromoles/liter Standard Deviation 2.04	0.7 micromoles/liter Standard Deviation 2.49

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Potassium (Micromoles/Liter)	0.13 micromoles/liter Standard Deviation 0.386	0.03 micromoles/liter Standard Deviation 0.386

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Chloride (Micromoles/Liter)	-0.4 micromoles/liter Standard Deviation 2.51	0.2 micromoles/liter Standard Deviation 3.65

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Bicarbonate (Micromoles/Liter)	-0.5 micromoles/liter Standard Deviation 2.79	-0.8 micromoles/liter Standard Deviation 3.28

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Albumin (Grams/Liter)	1.4 grams/liter Standard Deviation 3.48	1.3 grams/liter Standard Deviation 3.66

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Total Protein (Grams/Liter)	-6.3 grams/liter Standard Deviation 6.07	-7.2 grams/liter Standard Deviation 6.80

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Cholesterol (Micromoles/Liter)	0.808 micromoles/liter Standard Deviation 1.0327	1.113 micromoles/liter Standard Deviation 1.1699

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)	0.257 micromoles/liter Standard Deviation 0.3060	0.346 micromoles/liter Standard Deviation 0.3162

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)	0.535 micromoles/liter Standard Deviation 0.8583	0.715 micromoles/liter Standard Deviation 0.9831

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)	-0.056 ratio Standard Deviation 0.7798	-0.040 ratio Standard Deviation 0.9119

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Triglycerides (Micromoles/Liter)	0.846 micromoles/liter Standard Deviation 1.5874	1.103 micromoles/liter Standard Deviation 1.6805

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)	-0.122 milliliters/second Standard Deviation 0.3047	-0.024 milliliters/second Standard Deviation 0.3020

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=80 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)	-0.011 millimoles/liter Standard Deviation 0.7501	0.109 millimoles/liter Standard Deviation 1.1172

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=89 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=81 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)	-21.157 units/liter Standard Deviation 69.2920	-28.926 units/liter Standard Deviation 41.4161

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Lipase (Units/Liter)	4.674 units/liter Standard Deviation 54.3370	-1.898 units/liter Standard Deviation 24.5716

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Magnesium (Millimoles/Liter)	0.019 millimoles/liter Standard Deviation 0.0748	-0.009 millimoles/liter Standard Deviation 0.0763

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=89 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)	2.112 micrograms/milliliter Standard Deviation 7.3600	2.064 micrograms/milliliter Standard Deviation 4.9970

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=89 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=77 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)	-1.584 nanograms/liter Standard Deviation 9.4362	-53.286 nanograms/liter Standard Deviation 422.1502

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=86 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=74 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Lactate (Millimoles/Liter)	0.281 millimoles/liter Standard Deviation 0.6456	0.444 millimoles/liter Standard Deviation 1.2115

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=77 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)	-138.602 picograms/milliliter Standard Deviation 362.1327	-166.403 picograms/milliliter Standard Deviation 482.2808

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=77 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)	-1257.9 picograms/milliliter Standard Deviation 1354.75	-1594.7 picograms/milliliter Standard Deviation 1682.78

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Leptin (Nanograms/Milliliter)	3.623 nanograms/milliliter Standard Deviation 7.3797	2.927 nanograms/milliliter Standard Deviation 6.4420

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Included in measures of metabolic toxicity

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=91 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=81 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Insulin (Picomoles/Liter)	-6.724 picomoles/liter Standard Deviation 49.2087	4.441 picomoles/liter Standard Deviation 72.8859

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=83 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=77 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Urine Specific Gravity	0.0042 ratio of urine density to water density Standard Deviation 0.00742	0.0052 ratio of urine density to water density Standard Deviation 0.00746

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=83 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=77 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Urine pH	0.00 pH Standard Deviation 0.672	0.03 pH Standard Deviation 0.819

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)	-0.7 mm Hg Standard Deviation 16.45	-2.4 mm Hg Standard Deviation 15.20

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)	-2.4 mm Hg Standard Deviation 9.96	-1.8 mm Hg Standard Deviation 10.56

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=88 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=79 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)	-4.6 beats per minute Standard Deviation 13.30	-6.3 beats per minute Standard Deviation 13.72

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Weight (kg)	1.83 kg Standard Deviation 7.106	3.77 kg Standard Deviation 6.781

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=77 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Temperature (°F)	-0.152 °F Standard Deviation 0.8069	-0.183 °F Standard Deviation 0.8768

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=91 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=84 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Chest Measurement (cm)	1.13 cm Standard Deviation 6.010	4.06 cm Standard Deviation 18.903

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=92 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=84 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Waist Measurement (cm)	1.88 cm Standard Deviation 8.489	4.93 cm Standard Deviation 20.344

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=92 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=84 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Mid-Arm Measurement (cm)	1.76 cm Standard Deviation 19.688	4.71 cm Standard Deviation 20.844

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=92 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=84 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Hips Measurement (cm)	2.45 cm Standard Deviation 7.565	4.70 cm Standard Deviation 18.784

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=90 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=84 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Mid-Thigh Measurement (cm)	2.09 cm Standard Deviation 21.148	5.13 cm Standard Deviation 25.969

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)	7.28 grams Standard Deviation 31.953	21.53 grams Standard Deviation 52.911

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)	-1.49 grams Standard Deviation 7.725	-1.25 grams Standard Deviation 10.693

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)	-0.33 grams Standard Deviation 9.013	1.52 grams Standard Deviation 12.911

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)	15.32 grams Standard Deviation 31.250	28.82 grams Standard Deviation 49.855

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)	1.97 grams Standard Deviation 6.220	2.27 grams Standard Deviation 8.080

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)	4.32 grams Standard Deviation 9.797	6.96 grams Standard Deviation 11.466

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)	13.75 grams Standard Deviation 40.009	27.01 grams Standard Deviation 65.086

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)	1.67 grams Standard Deviation 5.988	2.56 grams Standard Deviation 7.248

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)	3.48 grams Standard Deviation 9.352	6.34 grams Standard Deviation 10.122

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)	12.71 grams Standard Deviation 33.543	25.31 grams Standard Deviation 53.892

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)	1.08 grams Standard Deviation 5.224	1.56 grams Standard Deviation 6.005

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)	2.9 grams Standard Deviation 8.52	5.4 grams Standard Deviation 9.42

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)	-3.69 grams Standard Deviation 5.224	0.52 grams Standard Deviation 5.861

SECONDARY outcome

Timeframe: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.

Outcome measures

Outcome measures
Measure	LPV/r + FTC/TDF n=82 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=78 Participants lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)	-2.48 grams/cm^2 Standard Deviation 3.797	0.68 grams/cm^2 Standard Deviation 4.614

Adverse Events

LPV/r + FTC/TDF

Serious events: 14 serious events

Other events: 96 other events

Deaths: 0 deaths

LPV/r + RAL

Serious events: 12 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	LPV/r + FTC/TDF n=105 participants at risk lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=101 participants at risk lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Gastrointestinal disorders Abdominal pain	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Cardiac disorders Acute myocardial infarction	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Anal abscess	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Anogenital warts	1.9% 2/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Appendicitis	1.9% 2/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Hepatobiliary disorders Bile duct stone	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Cardiac disorders Bradycardia	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Bronchitis	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Cellulitis	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	2.0% 2/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Clostridium difficile colitis	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Nervous system disorders Convulsion	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Cytomegalovirus infection	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Psychiatric disorders Drug abuse	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Drug toxicity	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Nervous system disorders Epilepsy	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Escherichia bacteraemia	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Gastroenteritis	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Infected sebaceous cyst	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Lymphogranuloma venereum	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Psychiatric disorders Major depression	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Cardiac disorders Myocardial infarction	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Pneumonia bacterial	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Gastrointestinal disorders Proctocolitis	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Renal and urinary disorders Renal failure	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Renal and urinary disorders Renal failure acute	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Scrotal infection	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Sepsis	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.99% 1/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Vascular disorders Thrombophlebitis	0.00% 0/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	2.0% 2/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Renal and urinary disorders Tubulointerstitial nephritis	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Typhoid fever	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	0.00% 0/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.

Measure	LPV/r + FTC/TDF n=105 participants at risk lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	LPV/r + RAL n=101 participants at risk lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Ear and labyrinth disorders Vertigo	2.9% 3/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Gastrointestinal disorders Vomiting	12.4% 13/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	7.9% 8/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Gastrointestinal disorders Abdominal pain	9.5% 10/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	4.0% 4/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Anogenital warts	6.7% 7/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	4.0% 4/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	7.6% 8/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	7.9% 8/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
General disorders Asthenia	7.6% 8/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	7.9% 8/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	8.6% 9/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Bronchitis	10.5% 11/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	9.5% 10/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	9.9% 10/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Psychiatric disorders Depression	10.5% 11/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	9.9% 10/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Gastrointestinal disorders Diarrhoea	61.0% 64/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	61.4% 62/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Nervous system disorders Dizziness	6.7% 7/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	4.0% 4/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Gastrointestinal disorders Dyspepsia	3.8% 4/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
General disorders Fatigue	6.7% 7/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	4.0% 4/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Gastrointestinal disorders Flatulence	8.6% 9/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	10.9% 11/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Folliculitis	0.95% 1/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	6.9% 7/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Gastroenteritis	5.7% 6/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.0% 5/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Nervous system disorders Headache	17.1% 18/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	12.9% 13/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	9.5% 10/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	14.9% 15/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Vascular disorders Hypertension	5.7% 6/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.7% 6/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	15.8% 16/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Influenza	3.8% 4/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	7.9% 8/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Psychiatric disorders Insomnia	9.5% 10/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	8.9% 9/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Nasopharyngitis	14.3% 15/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	10.9% 11/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Gastrointestinal disorders Nausea	19.0% 20/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	12.9% 13/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.5% 10/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Pharyngitis	3.8% 4/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
General disorders Pyrexia	8.6% 9/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Skin and subcutaneous tissue disorders Rash	3.8% 4/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	6.9% 7/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.7% 6/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	4.0% 4/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus congestion	5.7% 6/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	4.0% 4/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Sinusitis	7.6% 8/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Syphilis	4.8% 5/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	5.9% 6/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Upper respiratory tract infection	9.5% 10/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	13.9% 14/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
Infections and infestations Urinary tract infection	7.6% 8/105 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.	3.0% 3/101 • Week 96 Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.