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

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ClinicalTrials.gov Identifier: NCT00711009
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : February 2, 2011
Last Update Posted : February 14, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus Infection
Interventions Drug: lopinavir/ritonavir (LPV/r)
Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
Drug: raltegravir (RAL)
Enrollment 206
Recruitment Details  
Pre-assignment Details 3 additional participants were randomized but did not receive study drug and therefore were not included in the analyses.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Period Title: Overall Study
Started 105 101
Completed 90 82
Not Completed 15 19
Reason Not Completed
Adverse Event/HIV-Related Event             4             5
Withdrawal by Subject             4             2
Lost to Follow-up             3             9
Participant Noncompliant             0             1
Virologic Failure             2             1
Pregnancy             1             0
Site closing             0             1
Dose adjustment             1             0
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL Total
Hide Arm/Group Description lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily Total of all reporting groups
Overall Number of Baseline Participants 105 101 206
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 101 participants 206 participants
39.4  (11.24) 39.8  (9.94) 39.6  (10.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 101 participants 206 participants
Female
19
  18.1%
13
  12.9%
32
  15.5%
Male
86
  81.9%
88
  87.1%
174
  84.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 101 participants 206 participants
American Indian or Alaska Native 0 0 0
Asian 1 3 4
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 22 22 44
White 81 74 155
More than one race 0 1 1
Unknown or Not Reported 0 0 0
Other 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 101 participants 206 participants
North America 61 59 120
Europe 44 42 86
Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Level  
Mean (Standard Deviation)
Unit of measure:  Log10 copies/milliliter
Number Analyzed 105 participants 101 participants 206 participants
4.3  (0.76) 4.2  (0.83) 4.2  (0.79)
CD4+ T-Cell Counts  
Mean (Standard Deviation)
Unit of measure:  Cells/microliter
Number Analyzed 105 participants 101 participants 206 participants
297.6  (166.66) 289.3  (149.03) 293.5  (157.93)
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 105 101
Measure Type: Number
Unit of Measure: Percentage of Participants
84.8 83.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r + FTC/TDF, LPV/r + RAL
Comments The null hypothesis was that the response rate for the LPV/r + RAL arm was more than 20% lower than the response rate for the LPV/r + FTC/TDF arm. The planned sample size of 100 participants per treatment group provided 90% power to conclude that the LPV/r + RAL arm was non-inferior to the control arm, based on a non-inferiority margin of –20% (with a type I error rate of 0.05).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The exact 95% confidence interval for the difference in response rates (LPV/r + RAL minus LPV/r + FTC/TDF) was used to assess non-inferiority. The LPV/r+RAL arm was considered non-inferior to the LPV/r+FTC/TDF arm because the lower limit of the confidence interval was >/= -20%. Because the LPV/r+RAL arm was considered non-inferior based on the 20% margin, the results were assessed on a more rigorous 12% margin (-12%), as prespecified.
Statistical Test of Hypothesis P-Value 0.850
Comments [Not Specified]
Method exact binomial method
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff. in Percentage of Subj. Responding
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-12.0 to 8.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
Hide Description 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.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 105 101
Measure Type: Number
Unit of Measure: Percentage of participants
Any adverse event 34.3 30.7
Diarrhoea 16.2 7.9
Hyperchloresterolaemia 4.8 8.9
Hypertriglyceridaemia 2.9 5.9
Hyperlipidaemia 1.0 3.0
Blood triglycerides increased 1.9 3.0
Alanine aminotransferase increased 1.0 3.0
Aspartate aminotransferase increased 0 2
Asthenia 2.9 0
3.Primary Outcome
Title Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
Hide Description Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 104 101
Measure Type: Number
Unit of Measure: Percentage of participants
Alananine aminotransferase >5x upper limit normal 2.9 5.0
Aspartate aminotransferase >5x upper limit normal 2.9 5.0
Creatinine phosphokinase >4x upper limit of normal 8.7 19.8
Calcium <1.75 millimoles/liter 0 2
Cholesterol >7.77 millimoles/liter 13.5 16.8
Triglycerides >8.475 millimoles/liter 4.8 9.9
Calc. creatinine clearance <50 milliliters/minute 3.8 1.0
Lipase >2x upper limit of normal 7.7 4.0
Neutrophils < 0.75 x 10^9/liter 3.8 0
Magnesium < 0.5 millimoles/liter 0 2
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 105 101
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 2 7.6 33.7
Week 4 17.1 63.4
Week 8 36.2 75.2
Week 16 67.6 81.2
Week 24 80.0 83.2
Week 32 85.7 85.1
Week 40 84.8 87.1
Week 48 84.8 83.2
Week 60 82.9 75.2
Week 72 78.1 71.3
Week 84 74.3 70.3
Week 96 68.6 66.3
5.Secondary Outcome
Title Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 105 101
Mean (Standard Error)
Unit of Measure: cells/microliter
Week 4 97.2  (10.94) 113.4  (10.83)
Week 8 107.9  (12.07) 124.5  (12.20)
Week 16 158.7  (13.94) 141.6  (14.01)
Week 24 154.9  (13.76) 174.5  (13.99)
Week 32 180.0  (13.42) 188.2  (13.49)
Week 40 204.6  (15.22) 223.0  (15.55)
Week 48 245.0  (18.02) 241.9  (17.83)
Week 60 243.4  (18.05) 250.6  (18.45)
Week 72 277.4  (20.10) 269.9  (20.47)
Week 84 309.6  (19.83) 280.2  (21.05)
Week 96 296.4  (20.38) 281.0  (20.91)
6.Secondary Outcome
Title Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 105 101
Measure Type: Number
Unit of Measure: Percentage of Participants
79.1 77.8
7.Secondary Outcome
Title Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 5 8
Measure Type: Number
Unit of Measure: Participants
Lopinavir resistance 0 0
Emtricitabine resistance 1 0
Tenofovir resistance 0 0
Raltegravir resistance NA [1]  3
[1]
Participants in this treatment group did not receive raltegravir; as a result, the potential for developing resistance to raltegravir is not applicable.
8.Secondary Outcome
Title Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 5 8
Measure Type: Number
Unit of Measure: Participants
0 1
9.Secondary Outcome
Title Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 75 67
Mean (Standard Error)
Unit of Measure: Scores on a scale
-1.0  (1.34) -1.1  (1.51)
10.Secondary Outcome
Title Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 75 67
Mean (Standard Error)
Unit of Measure: Scores on a scale
1.3  (1.44) 1.3  (1.62)
11.Secondary Outcome
Title Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
Hide Description 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.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 84 80
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
75.5  (23.29) 76.0  (27.47)
12.Secondary Outcome
Title Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
Hide Description 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.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 85 80
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
84.6  (17.56) 86.2  (19.15)
13.Secondary Outcome
Title Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
Hide Description 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.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 85 80
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
82.5  (15.49) 85.5  (15.62)
14.Secondary Outcome
Title Mean Change From Baseline in Hemoglobin (Grams/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: grams/liter
5.4  (13.26) 5.1  (13.05)
15.Secondary Outcome
Title Mean Change From Baseline in Hematocrit (Fraction)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: % by volume of packed RBCs in blood
0.038  (0.0379) 0.036  (0.0386)
16.Secondary Outcome
Title Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: number of cells x 10^12/liter
0.12  (0.450) 0.16  (0.471)
17.Secondary Outcome
Title Mean Change From Baseline in Platelet Count (x 10^9/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: number of cells x 10^9/liter
46.8  (69.18) 34.2  (68.94)
18.Secondary Outcome
Title Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: number of cells x 10^9/liter
0.90  (1.717) 1.20  (1.670)
19.Secondary Outcome
Title Mean Change From Baseline in Neutrophils (x 10^9/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: number of cells x 10^9/liter
0.509  (1.2256) 0.705  (1.2836)
20.Secondary Outcome
Title Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: number of cells x 10^9/liter
0.332  (0.6901) 0.368  (0.8068)
21.Secondary Outcome
Title Mean Change From Baseline in Monocytes (x 10^9/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: number of cells x 10^9/liter
0.065  (0.1435) 0.112  (0.1436)
22.Secondary Outcome
Title Mean Change From Baseline in Eosinophils (x 10^9/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: number of cells x 10^9/liter
-0.012  (0.0817) 0.015  (0.1063)
23.Secondary Outcome
Title Mean Change From Baseline in Basophils (x 10^9/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 82
Mean (Standard Deviation)
Unit of Measure: number of cells x 10^9/liter
0.005  (0.0233) 0.003  (0.0222)
24.Secondary Outcome
Title Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: units/liter
-6.1  (41.45) -13.4  (39.96)
25.Secondary Outcome
Title Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: units/liter
-0.8  (64.29) -9.6  (37.86)
26.Secondary Outcome
Title Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: units/liter
14.5  (20.26) 1.7  (24.53)
27.Secondary Outcome
Title Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: units/liter
398.9  (3381.10) 157.2  (1081.24)
28.Secondary Outcome
Title Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
0.9  (4.17) 1.9  (6.16)
29.Secondary Outcome
Title Mean Change From Baseline in Creatinine (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
5.7  (12.66) 1.6  (11.54)
30.Secondary Outcome
Title Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
0.00  (1.390) 0.37  (1.658)
31.Secondary Outcome
Title Mean Change From Baseline in Uric Acid (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
-29.0  (65.25) -6.1  (66.29)
32.Secondary Outcome
Title Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
-0.046  (0.1645) -0.028  (0.2391)
33.Secondary Outcome
Title Mean Change From Baseline in Calcium (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
-0.040  (0.1071) -0.016  (0.1468)
34.Secondary Outcome
Title Mean Change From Baseline in Sodium (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
0.1  (2.04) 0.7  (2.49)
35.Secondary Outcome
Title Mean Change From Baseline in Potassium (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
0.13  (0.386) 0.03  (0.386)
36.Secondary Outcome
Title Mean Change From Baseline in Chloride (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
-0.4  (2.51) 0.2  (3.65)
37.Secondary Outcome
Title Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
-0.5  (2.79) -0.8  (3.28)
38.Secondary Outcome
Title Mean Change From Baseline in Albumin (Grams/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: grams/liter
1.4  (3.48) 1.3  (3.66)
39.Secondary Outcome
Title Mean Change From Baseline in Total Protein (Grams/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: grams/liter
-6.3  (6.07) -7.2  (6.80)
40.Secondary Outcome
Title Mean Change From Baseline in Cholesterol (Micromoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
0.808  (1.0327) 1.113  (1.1699)
41.Secondary Outcome
Title Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
0.257  (0.3060) 0.346  (0.3162)
42.Secondary Outcome
Title Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
0.535  (0.8583) 0.715  (0.9831)
43.Secondary Outcome
Title Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: ratio
-0.056  (0.7798) -0.040  (0.9119)
44.Secondary Outcome
Title Mean Change From Baseline in Triglycerides (Micromoles/Liter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: micromoles/liter
0.846  (1.5874) 1.103  (1.6805)
45.Secondary Outcome
Title Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: milliliters/second
-0.122  (0.3047) -0.024  (0.3020)
46.Secondary Outcome
Title Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 80
Mean (Standard Deviation)
Unit of Measure: millimoles/liter
-0.011  (0.7501) 0.109  (1.1172)
47.Secondary Outcome
Title Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 89 81
Mean (Standard Deviation)
Unit of Measure: units/liter
-21.157  (69.2920) -28.926  (41.4161)
48.Secondary Outcome
Title Mean Change From Baseline in Lipase (Units/Liter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: units/liter
4.674  (54.3370) -1.898  (24.5716)
49.Secondary Outcome
Title Mean Change From Baseline in Magnesium (Millimoles/Liter)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: millimoles/liter
0.019  (0.0748) -0.009  (0.0763)
50.Secondary Outcome
Title Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 89 78
Mean (Standard Deviation)
Unit of Measure: micrograms/milliliter
2.112  (7.3600) 2.064  (4.9970)
51.Secondary Outcome
Title Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 89 77
Mean (Standard Deviation)
Unit of Measure: nanograms/liter
-1.584  (9.4362) -53.286  (422.1502)
52.Secondary Outcome
Title Mean Change From Baseline in Lactate (Millimoles/Liter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 86 74
Mean (Standard Deviation)
Unit of Measure: millimoles/liter
0.281  (0.6456) 0.444  (1.2115)
53.Secondary Outcome
Title Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 77
Mean (Standard Deviation)
Unit of Measure: picograms/milliliter
-138.602  (362.1327) -166.403  (482.2808)
54.Secondary Outcome
Title Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 77
Mean (Standard Deviation)
Unit of Measure: picograms/milliliter
-1257.9  (1354.75) -1594.7  (1682.78)
55.Secondary Outcome
Title Mean Change From Baseline in Leptin (Nanograms/Milliliter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 78
Mean (Standard Deviation)
Unit of Measure: nanograms/milliliter
3.623  (7.3797) 2.927  (6.4420)
56.Secondary Outcome
Title Mean Change From Baseline in Insulin (Picomoles/Liter)
Hide Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 91 81
Mean (Standard Deviation)
Unit of Measure: picomoles/liter
-6.724  (49.2087) 4.441  (72.8859)
57.Secondary Outcome
Title Mean Change From Baseline in Urine Specific Gravity
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 83 77
Mean (Standard Deviation)
Unit of Measure: ratio of urine density to water density
0.0042  (0.00742) 0.0052  (0.00746)
58.Secondary Outcome
Title Mean Change From Baseline in Urine pH
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 83 77
Mean (Standard Deviation)
Unit of Measure: pH
0.00  (0.672) 0.03  (0.819)
59.Secondary Outcome
Title Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: mm Hg
-0.7  (16.45) -2.4  (15.20)
60.Secondary Outcome
Title Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: mm Hg
-2.4  (9.96) -1.8  (10.56)
61.Secondary Outcome
Title Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 88 79
Mean (Standard Deviation)
Unit of Measure: beats per minute
-4.6  (13.30) -6.3  (13.72)
62.Secondary Outcome
Title Mean Change From Baseline in Weight (kg)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 82
Mean (Standard Deviation)
Unit of Measure: kg
1.83  (7.106) 3.77  (6.781)
63.Secondary Outcome
Title Mean Change From Baseline in Temperature (°F)
Hide Description [Not Specified]
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 77
Mean (Standard Deviation)
Unit of Measure: °F
-0.152  (0.8069) -0.183  (0.8768)
64.Secondary Outcome
Title Mean Change From Baseline in Chest Measurement (cm)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 were included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 91 84
Mean (Standard Deviation)
Unit of Measure: cm
1.13  (6.010) 4.06  (18.903)
65.Secondary Outcome
Title Mean Change From Baseline in Waist Measurement (cm)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 92 84
Mean (Standard Deviation)
Unit of Measure: cm
1.88  (8.489) 4.93  (20.344)
66.Secondary Outcome
Title Mean Change From Baseline in Mid-Arm Measurement (cm)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 92 84
Mean (Standard Deviation)
Unit of Measure: cm
1.76  (19.688) 4.71  (20.844)
67.Secondary Outcome
Title Mean Change From Baseline in Hips Measurement (cm)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 92 84
Mean (Standard Deviation)
Unit of Measure: cm
2.45  (7.565) 4.70  (18.784)
68.Secondary Outcome
Title Mean Change From Baseline in Mid-Thigh Measurement (cm)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 90 84
Mean (Standard Deviation)
Unit of Measure: cm
2.09  (21.148) 5.13  (25.969)
69.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
7.28  (31.953) 21.53  (52.911)
70.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
-1.49  (7.725) -1.25  (10.693)
71.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
-0.33  (9.013) 1.52  (12.911)
72.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
15.32  (31.250) 28.82  (49.855)
73.Secondary Outcome
Title Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
1.97  (6.220) 2.27  (8.080)
74.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
4.32  (9.797) 6.96  (11.466)
75.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
13.75  (40.009) 27.01  (65.086)
76.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
1.67  (5.988) 2.56  (7.248)
77.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
3.48  (9.352) 6.34  (10.122)
78.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
12.71  (33.543) 25.31  (53.892)
79.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
1.08  (5.224) 1.56  (6.005)
80.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)
Hide Description 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.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
2.9  (8.52) 5.4  (9.42)
81.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)
Hide Description The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams
-3.69  (5.224) 0.52  (5.861)
82.Secondary Outcome
Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)
Hide Description The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.
Time Frame Baseline to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who had values at Baseline and Week 96 are included in the analysis.
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description:
lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Overall Number of Participants Analyzed 82 78
Mean (Standard Deviation)
Unit of Measure: grams/cm^2
-2.48  (3.797) 0.68  (4.614)
Time Frame Week 96
Adverse Event Reporting Description Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug.
 
Arm/Group Title LPV/r + FTC/TDF LPV/r + RAL
Hide Arm/Group Description lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
All-Cause Mortality
LPV/r + FTC/TDF LPV/r + RAL
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LPV/r + FTC/TDF LPV/r + RAL
Affected / at Risk (%) Affected / at Risk (%)
Total   14/105 (13.33%)   12/101 (11.88%) 
Cardiac disorders     
Acute myocardial infarction  1/105 (0.95%)  0/101 (0.00%) 
Bradycardia  1/105 (0.95%)  0/101 (0.00%) 
Myocardial infarction  0/105 (0.00%)  1/101 (0.99%) 
Gastrointestinal disorders     
Abdominal pain  1/105 (0.95%)  0/101 (0.00%) 
Proctocolitis  0/105 (0.00%)  1/101 (0.99%) 
Hepatobiliary disorders     
Bile duct stone  0/105 (0.00%)  1/101 (0.99%) 
Infections and infestations     
Anal abscess  1/105 (0.95%)  0/101 (0.00%) 
Anogenital warts  2/105 (1.90%)  0/101 (0.00%) 
Appendicitis  2/105 (1.90%)  1/101 (0.99%) 
Bronchitis  1/105 (0.95%)  0/101 (0.00%) 
Cellulitis  0/105 (0.00%)  2/101 (1.98%) 
Clostridium difficile colitis  1/105 (0.95%)  0/101 (0.00%) 
Cytomegalovirus infection  0/105 (0.00%)  1/101 (0.99%) 
Escherichia bacteraemia  0/105 (0.00%)  1/101 (0.99%) 
Gastroenteritis  1/105 (0.95%)  1/101 (0.99%) 
Infected sebaceous cyst  1/105 (0.95%)  0/101 (0.00%) 
Lymphogranuloma venereum  0/105 (0.00%)  1/101 (0.99%) 
Pneumonia bacterial  0/105 (0.00%)  1/101 (0.99%) 
Scrotal infection  0/105 (0.00%)  1/101 (0.99%) 
Sepsis  0/105 (0.00%)  1/101 (0.99%) 
Typhoid fever  1/105 (0.95%)  0/101 (0.00%) 
Injury, poisoning and procedural complications     
Drug toxicity  0/105 (0.00%)  1/101 (0.99%) 
Nervous system disorders     
Convulsion  0/105 (0.00%)  1/101 (0.99%) 
Epilepsy  1/105 (0.95%)  0/101 (0.00%) 
Subarachnoid haemorrhage  0/105 (0.00%)  1/101 (0.99%) 
Psychiatric disorders     
Drug abuse  1/105 (0.95%)  0/101 (0.00%) 
Major depression  1/105 (0.95%)  0/101 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1/105 (0.95%)  0/101 (0.00%) 
Renal failure  0/105 (0.00%)  1/101 (0.99%) 
Renal failure acute  1/105 (0.95%)  0/101 (0.00%) 
Tubulointerstitial nephritis  1/105 (0.95%)  0/101 (0.00%) 
Vascular disorders     
Deep vein thrombosis  0/105 (0.00%)  1/101 (0.99%) 
Thrombophlebitis  0/105 (0.00%)  2/101 (1.98%) 
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LPV/r + FTC/TDF LPV/r + RAL
Affected / at Risk (%) Affected / at Risk (%)
Total   96/105 (91.43%)   94/101 (93.07%) 
Ear and labyrinth disorders     
Vertigo  3/105 (2.86%)  6/101 (5.94%) 
Gastrointestinal disorders     
Abdominal pain  10/105 (9.52%)  4/101 (3.96%) 
Diarrhoea  64/105 (60.95%)  62/101 (61.39%) 
Dyspepsia  4/105 (3.81%)  6/101 (5.94%) 
Flatulence  9/105 (8.57%)  11/101 (10.89%) 
Nausea  20/105 (19.05%)  13/101 (12.87%) 
Vomiting  13/105 (12.38%)  8/101 (7.92%) 
General disorders     
Asthenia  8/105 (7.62%)  8/101 (7.92%) 
Fatigue  7/105 (6.67%)  4/101 (3.96%) 
Pyrexia  9/105 (8.57%)  6/101 (5.94%) 
Infections and infestations     
Anogenital warts  7/105 (6.67%)  4/101 (3.96%) 
Bronchitis  11/105 (10.48%)  6/101 (5.94%) 
Folliculitis  1/105 (0.95%)  7/101 (6.93%) 
Gastroenteritis  6/105 (5.71%)  5/101 (4.95%) 
Influenza  4/105 (3.81%)  8/101 (7.92%) 
Nasopharyngitis  15/105 (14.29%)  11/101 (10.89%) 
Pharyngitis  4/105 (3.81%)  6/101 (5.94%) 
Sinusitis  8/105 (7.62%)  6/101 (5.94%) 
Syphilis  5/105 (4.76%)  6/101 (5.94%) 
Upper respiratory tract infection  10/105 (9.52%)  14/101 (13.86%) 
Urinary tract infection  8/105 (7.62%)  3/101 (2.97%) 
Metabolism and nutrition disorders     
Hypercholesterolaemia  10/105 (9.52%)  15/101 (14.85%) 
Hypertriglyceridaemia  6/105 (5.71%)  16/101 (15.84%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  8/105 (7.62%)  8/101 (7.92%) 
Back pain  9/105 (8.57%)  6/101 (5.94%) 
Nervous system disorders     
Dizziness  7/105 (6.67%)  4/101 (3.96%) 
Headache  18/105 (17.14%)  13/101 (12.87%) 
Psychiatric disorders     
Depression  11/105 (10.48%)  10/101 (9.90%) 
Insomnia  10/105 (9.52%)  9/101 (8.91%) 
Respiratory, thoracic and mediastinal disorders     
Cough  10/105 (9.52%)  10/101 (9.90%) 
Oropharyngeal pain  10/105 (9.52%)  6/101 (5.94%) 
Rhinorrhoea  6/105 (5.71%)  4/101 (3.96%) 
Sinus congestion  6/105 (5.71%)  4/101 (3.96%) 
Skin and subcutaneous tissue disorders     
Rash  4/105 (3.81%)  7/101 (6.93%) 
Vascular disorders     
Hypertension  6/105 (5.71%)  6/101 (5.94%) 
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00711009     History of Changes
Other Study ID Numbers: M10-336
2008-000881-22 ( EudraCT Number )
First Submitted: July 3, 2008
First Posted: July 8, 2008
Results First Submitted: November 16, 2010
Results First Posted: February 2, 2011
Last Update Posted: February 14, 2012