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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00711009
First received: July 3, 2008
Last updated: February 13, 2012
Last verified: February 2012
Results First Received: November 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 additional participants were randomized but did not receive study drug and therefore were not included in the analyses.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    LPV/r + FTC/TDF     LPV/r + RAL  
STARTED     105     101  
COMPLETED     90     82  
NOT COMPLETED     15     19  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    LPV/r + FTC/TDF     LPV/r + RAL     Total  
Number of Participants  
[units: participants]
  105     101     206  
Age  
[units: years]
Mean ± Standard Deviation
  39.4  ± 11.24     39.8  ± 9.94     39.6  ± 10.60  
Gender  
[units: participants]
     
Female     19     13     32  
Male     86     88     174  
Race/Ethnicity, Customized  
[units: 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  
[units: participants]
     
North America     61     59     120  
Europe     44     42     86  
Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Level  
[units: log10 copies/milliliter]
Mean ± Standard Deviation
  4.3  ± 0.76     4.2  ± 0.83     4.2  ± 0.79  
CD4+ T-Cell Counts  
[units: cells/microliter]
Mean ± Standard Deviation
  297.6  ± 166.66     289.3  ± 149.03     293.5  ± 157.93  



  Outcome Measures
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1.  Primary:   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   [ Time Frame: Baseline to Week 48 ]

Measure Type Primary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  105     101  
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  
[units: Percentage of Participants]
  84.8     83.2  


Statistical Analysis 1 for 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
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] exact binomial method
P Value [4] 0.850
Diff. in Percentage of Subj. Responding [5] -1.6
95% Confidence Interval ( -12.0 to 8.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  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).
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  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.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



2.  Primary:   Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events   [ Time Frame: Week 96 ]

Measure Type Primary
Measure Title Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  105     101  
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events  
[units: 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  

No statistical analysis provided for Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events



3.  Primary:   Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values   [ Time Frame: Baseline to Week 96 ]

Measure Type Primary
Measure Title Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  104     101  
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values  
[units: 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  

No statistical analysis provided for Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values



4.  Secondary:   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   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure 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
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  105     101  
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  
[units: 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  

No statistical analysis provided for 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



5.  Secondary:   Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  105     101  
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit  
[units: cells/microliter]
Mean ± Standard Error
   
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  

No statistical analysis provided for Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit



6.  Secondary:   Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  105     101  
Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672  
[units: Percentage of Participants]
  79.1     77.8  

No statistical analysis provided for Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672



7.  Secondary:   Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure 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.
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  5     8  
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.  
[units: 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.

No statistical analysis provided for Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.



8.  Secondary:   Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  5     8  
Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir  
[units: Participants]
  0     1  

No statistical analysis provided for Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir



9.  Secondary:   Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  75     67  
Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey  
[units: Scores on a scale]
Mean ± Standard Error
  -1.0  ± 1.34     -1.1  ± 1.51  

No statistical analysis provided for Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey



10.  Secondary:   Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  75     67  
Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey  
[units: Scores on a scale]
Mean ± Standard Error
  1.3  ± 1.44     1.3  ± 1.62  

No statistical analysis provided for Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey



11.  Secondary:   Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  84     80  
Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)  
[units: Scores on a scale]
Mean ± Standard Deviation
  75.5  ± 23.29     76.0  ± 27.47  

No statistical analysis provided for Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)



12.  Secondary:   Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  85     80  
Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication  
[units: Scores on a scale]
Mean ± Standard Deviation
  84.6  ± 17.56     86.2  ± 19.15  

No statistical analysis provided for Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication



13.  Secondary:   Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
Measure 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  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  85     80  
Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication  
[units: Scores on a scale]
Mean ± Standard Deviation
  82.5  ± 15.49     85.5  ± 15.62  

No statistical analysis provided for Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication



14.  Secondary:   Mean Change From Baseline in Hemoglobin (Grams/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Hemoglobin (Grams/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in Hemoglobin (Grams/Liter)  
[units: grams/liter]
Mean ± Standard Deviation
  5.4  ± 13.26     5.1  ± 13.05  

No statistical analysis provided for Mean Change From Baseline in Hemoglobin (Grams/Liter)



15.  Secondary:   Mean Change From Baseline in Hematocrit (Fraction)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Hematocrit (Fraction)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in Hematocrit (Fraction)  
[units: % by volume of packed RBCs in blood]
Mean ± Standard Deviation
  0.038  ± 0.0379     0.036  ± 0.0386  

No statistical analysis provided for Mean Change From Baseline in Hematocrit (Fraction)



16.  Secondary:   Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)  
[units: number of cells x 10^12/liter]
Mean ± Standard Deviation
  0.12  ± 0.450     0.16  ± 0.471  

No statistical analysis provided for Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)



17.  Secondary:   Mean Change From Baseline in Platelet Count (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Platelet Count (x 10^9/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in Platelet Count (x 10^9/Liter)  
[units: number of cells x 10^9/liter]
Mean ± Standard Deviation
  46.8  ± 69.18     34.2  ± 68.94  

No statistical analysis provided for Mean Change From Baseline in Platelet Count (x 10^9/Liter)



18.  Secondary:   Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)  
[units: number of cells x 10^9/liter]
Mean ± Standard Deviation
  0.90  ± 1.717     1.20  ± 1.670  

No statistical analysis provided for Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)



19.  Secondary:   Mean Change From Baseline in Neutrophils (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Neutrophils (x 10^9/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in Neutrophils (x 10^9/Liter)  
[units: number of cells x 10^9/liter]
Mean ± Standard Deviation
  0.509  ± 1.2256     0.705  ± 1.2836  

No statistical analysis provided for Mean Change From Baseline in Neutrophils (x 10^9/Liter)



20.  Secondary:   Mean Change From Baseline in Lymphocytes (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in Lymphocytes (x 10^9/Liter)  
[units: number of cells x 10^9/liter]
Mean ± Standard Deviation
  0.332  ± 0.6901     0.368  ± 0.8068  

No statistical analysis provided for Mean Change From Baseline in Lymphocytes (x 10^9/Liter)



21.  Secondary:   Mean Change From Baseline in Monocytes (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Monocytes (x 10^9/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in Monocytes (x 10^9/Liter)  
[units: number of cells x 10^9/liter]
Mean ± Standard Deviation
  0.065  ± 0.1435     0.112  ± 0.1436  

No statistical analysis provided for Mean Change From Baseline in Monocytes (x 10^9/Liter)



22.  Secondary:   Mean Change From Baseline in Eosinophils (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Eosinophils (x 10^9/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in Eosinophils (x 10^9/Liter)  
[units: number of cells x 10^9/liter]
Mean ± Standard Deviation
  -0.012  ± 0.0817     0.015  ± 0.1063  

No statistical analysis provided for Mean Change From Baseline in Eosinophils (x 10^9/Liter)



23.  Secondary:   Mean Change From Baseline in Basophils (x 10^9/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Basophils (x 10^9/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     82  
Mean Change From Baseline in Basophils (x 10^9/Liter)  
[units: number of cells x 10^9/liter]
Mean ± Standard Deviation
  0.005  ± 0.0233     0.003  ± 0.0222  

No statistical analysis provided for Mean Change From Baseline in Basophils (x 10^9/Liter)



24.  Secondary:   Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)  
[units: units/liter]
Mean ± Standard Deviation
  -6.1  ± 41.45     -13.4  ± 39.96  

No statistical analysis provided for Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)



25.  Secondary:   Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)  
[units: units/liter]
Mean ± Standard Deviation
  -0.8  ± 64.29     -9.6  ± 37.86  

No statistical analysis provided for Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)



26.  Secondary:   Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)  
[units: units/liter]
Mean ± Standard Deviation
  14.5  ± 20.26     1.7  ± 24.53  

No statistical analysis provided for Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)



27.  Secondary:   Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)  
[units: units/liter]
Mean ± Standard Deviation
  398.9  ± 3381.10     157.2  ± 1081.24  

No statistical analysis provided for Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)



28.  Secondary:   Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  0.9  ± 4.17     1.9  ± 6.16  

No statistical analysis provided for Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)



29.  Secondary:   Mean Change From Baseline in Creatinine (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Creatinine (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Creatinine (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  5.7  ± 12.66     1.6  ± 11.54  

No statistical analysis provided for Mean Change From Baseline in Creatinine (Micromoles/Liter)



30.  Secondary:   Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  0.00  ± 1.390     0.37  ± 1.658  

No statistical analysis provided for Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)



31.  Secondary:   Mean Change From Baseline in Uric Acid (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Uric Acid (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Uric Acid (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  -29.0  ± 65.25     -6.1  ± 66.29  

No statistical analysis provided for Mean Change From Baseline in Uric Acid (Micromoles/Liter)



32.  Secondary:   Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  -0.046  ± 0.1645     -0.028  ± 0.2391  

No statistical analysis provided for Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)



33.  Secondary:   Mean Change From Baseline in Calcium (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Calcium (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Calcium (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  -0.040  ± 0.1071     -0.016  ± 0.1468  

No statistical analysis provided for Mean Change From Baseline in Calcium (Micromoles/Liter)



34.  Secondary:   Mean Change From Baseline in Sodium (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Sodium (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Sodium (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  0.1  ± 2.04     0.7  ± 2.49  

No statistical analysis provided for Mean Change From Baseline in Sodium (Micromoles/Liter)



35.  Secondary:   Mean Change From Baseline in Potassium (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Potassium (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Potassium (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  0.13  ± 0.386     0.03  ± 0.386  

No statistical analysis provided for Mean Change From Baseline in Potassium (Micromoles/Liter)



36.  Secondary:   Mean Change From Baseline in Chloride (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Chloride (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Chloride (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  -0.4  ± 2.51     0.2  ± 3.65  

No statistical analysis provided for Mean Change From Baseline in Chloride (Micromoles/Liter)



37.  Secondary:   Mean Change From Baseline in Bicarbonate (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Bicarbonate (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  -0.5  ± 2.79     -0.8  ± 3.28  

No statistical analysis provided for Mean Change From Baseline in Bicarbonate (Micromoles/Liter)



38.  Secondary:   Mean Change From Baseline in Albumin (Grams/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Albumin (Grams/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Albumin (Grams/Liter)  
[units: grams/liter]
Mean ± Standard Deviation
  1.4  ± 3.48     1.3  ± 3.66  

No statistical analysis provided for Mean Change From Baseline in Albumin (Grams/Liter)



39.  Secondary:   Mean Change From Baseline in Total Protein (Grams/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Total Protein (Grams/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Total Protein (Grams/Liter)  
[units: grams/liter]
Mean ± Standard Deviation
  -6.3  ± 6.07     -7.2  ± 6.80  

No statistical analysis provided for Mean Change From Baseline in Total Protein (Grams/Liter)



40.  Secondary:   Mean Change From Baseline in Cholesterol (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Cholesterol (Micromoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Cholesterol (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  0.808  ± 1.0327     1.113  ± 1.1699  

No statistical analysis provided for Mean Change From Baseline in Cholesterol (Micromoles/Liter)



41.  Secondary:   Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  0.257  ± 0.3060     0.346  ± 0.3162  

No statistical analysis provided for Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)



42.  Secondary:   Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  0.535  ± 0.8583     0.715  ± 0.9831  

No statistical analysis provided for Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)



43.  Secondary:   Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)  
[units: ratio]
Mean ± Standard Deviation
  -0.056  ± 0.7798     -0.040  ± 0.9119  

No statistical analysis provided for Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)



44.  Secondary:   Mean Change From Baseline in Triglycerides (Micromoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Triglycerides (Micromoles/Liter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Triglycerides (Micromoles/Liter)  
[units: micromoles/liter]
Mean ± Standard Deviation
  0.846  ± 1.5874     1.103  ± 1.6805  

No statistical analysis provided for Mean Change From Baseline in Triglycerides (Micromoles/Liter)



45.  Secondary:   Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)  
[units: milliliters/second]
Mean ± Standard Deviation
  -0.122  ± 0.3047     -0.024  ± 0.3020  

No statistical analysis provided for Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)



46.  Secondary:   Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     80  
Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)  
[units: millimoles/liter]
Mean ± Standard Deviation
  -0.011  ± 0.7501     0.109  ± 1.1172  

No statistical analysis provided for Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)



47.  Secondary:   Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  89     81  
Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)  
[units: units/liter]
Mean ± Standard Deviation
  -21.157  ± 69.2920     -28.926  ± 41.4161  

No statistical analysis provided for Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)



48.  Secondary:   Mean Change From Baseline in Lipase (Units/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Lipase (Units/Liter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Lipase (Units/Liter)  
[units: units/liter]
Mean ± Standard Deviation
  4.674  ± 54.3370     -1.898  ± 24.5716  

No statistical analysis provided for Mean Change From Baseline in Lipase (Units/Liter)



49.  Secondary:   Mean Change From Baseline in Magnesium (Millimoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Magnesium (Millimoles/Liter)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Magnesium (Millimoles/Liter)  
[units: millimoles/liter]
Mean ± Standard Deviation
  0.019  ± 0.0748     -0.009  ± 0.0763  

No statistical analysis provided for Mean Change From Baseline in Magnesium (Millimoles/Liter)



50.  Secondary:   Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  89     78  
Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)  
[units: micrograms/milliliter]
Mean ± Standard Deviation
  2.112  ± 7.3600     2.064  ± 4.9970  

No statistical analysis provided for Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)



51.  Secondary:   Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  89     77  
Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)  
[units: nanograms/liter]
Mean ± Standard Deviation
  -1.584  ± 9.4362     -53.286  ± 422.1502  

No statistical analysis provided for Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)



52.  Secondary:   Mean Change From Baseline in Lactate (Millimoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Lactate (Millimoles/Liter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  86     74  
Mean Change From Baseline in Lactate (Millimoles/Liter)  
[units: millimoles/liter]
Mean ± Standard Deviation
  0.281  ± 0.6456     0.444  ± 1.2115  

No statistical analysis provided for Mean Change From Baseline in Lactate (Millimoles/Liter)



53.  Secondary:   Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     77  
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)  
[units: picograms/milliliter]
Mean ± Standard Deviation
  -138.602  ± 362.1327     -166.403  ± 482.2808  

No statistical analysis provided for Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)



54.  Secondary:   Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     77  
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)  
[units: picograms/milliliter]
Mean ± Standard Deviation
  -1257.9  ± 1354.75     -1594.7  ± 1682.78  

No statistical analysis provided for Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)



55.  Secondary:   Mean Change From Baseline in Leptin (Nanograms/Milliliter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Leptin (Nanograms/Milliliter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     78  
Mean Change From Baseline in Leptin (Nanograms/Milliliter)  
[units: nanograms/milliliter]
Mean ± Standard Deviation
  3.623  ± 7.3797     2.927  ± 6.4420  

No statistical analysis provided for Mean Change From Baseline in Leptin (Nanograms/Milliliter)



56.  Secondary:   Mean Change From Baseline in Insulin (Picomoles/Liter)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Insulin (Picomoles/Liter)
Measure Description Included in measures of metabolic toxicity
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  91     81  
Mean Change From Baseline in Insulin (Picomoles/Liter)  
[units: picomoles/liter]
Mean ± Standard Deviation
  -6.724  ± 49.2087     4.441  ± 72.8859  

No statistical analysis provided for Mean Change From Baseline in Insulin (Picomoles/Liter)



57.  Secondary:   Mean Change From Baseline in Urine Specific Gravity   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Urine Specific Gravity
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  83     77  
Mean Change From Baseline in Urine Specific Gravity  
[units: ratio of urine density to water density]
Mean ± Standard Deviation
  0.0042  ± 0.00742     0.0052  ± 0.00746  

No statistical analysis provided for Mean Change From Baseline in Urine Specific Gravity



58.  Secondary:   Mean Change From Baseline in Urine pH   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Urine pH
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  83     77  
Mean Change From Baseline in Urine pH  
[units: pH]
Mean ± Standard Deviation
  0.00  ± 0.672     0.03  ± 0.819  

No statistical analysis provided for Mean Change From Baseline in Urine pH



59.  Secondary:   Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)  
[units: mm Hg]
Mean ± Standard Deviation
  -0.7  ± 16.45     -2.4  ± 15.20  

No statistical analysis provided for Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)



60.  Secondary:   Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)  
[units: mm Hg]
Mean ± Standard Deviation
  -2.4  ± 9.96     -1.8  ± 10.56  

No statistical analysis provided for Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)



61.  Secondary:   Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  88     79  
Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)  
[units: beats per minute]
Mean ± Standard Deviation
  -4.6  ± 13.30     -6.3  ± 13.72  

No statistical analysis provided for Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)



62.  Secondary:   Mean Change From Baseline in Weight (kg)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Weight (kg)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     82  
Mean Change From Baseline in Weight (kg)  
[units: kg]
Mean ± Standard Deviation
  1.83  ± 7.106     3.77  ± 6.781  

No statistical analysis provided for Mean Change From Baseline in Weight (kg)



63.  Secondary:   Mean Change From Baseline in Temperature (°F)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Temperature (°F)
Measure Description No text entered.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     77  
Mean Change From Baseline in Temperature (°F)  
[units: °F]
Mean ± Standard Deviation
  -0.152  ± 0.8069     -0.183  ± 0.8768  

No statistical analysis provided for Mean Change From Baseline in Temperature (°F)



64.  Secondary:   Mean Change From Baseline in Chest Measurement (cm)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Chest Measurement (cm)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 were included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  91     84  
Mean Change From Baseline in Chest Measurement (cm)  
[units: cm]
Mean ± Standard Deviation
  1.13  ± 6.010     4.06  ± 18.903  

No statistical analysis provided for Mean Change From Baseline in Chest Measurement (cm)



65.  Secondary:   Mean Change From Baseline in Waist Measurement (cm)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Waist Measurement (cm)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  92     84  
Mean Change From Baseline in Waist Measurement (cm)  
[units: cm]
Mean ± Standard Deviation
  1.88  ± 8.489     4.93  ± 20.344  

No statistical analysis provided for Mean Change From Baseline in Waist Measurement (cm)



66.  Secondary:   Mean Change From Baseline in Mid-Arm Measurement (cm)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Mid-Arm Measurement (cm)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  92     84  
Mean Change From Baseline in Mid-Arm Measurement (cm)  
[units: cm]
Mean ± Standard Deviation
  1.76  ± 19.688     4.71  ± 20.844  

No statistical analysis provided for Mean Change From Baseline in Mid-Arm Measurement (cm)



67.  Secondary:   Mean Change From Baseline in Hips Measurement (cm)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Hips Measurement (cm)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  92     84  
Mean Change From Baseline in Hips Measurement (cm)  
[units: cm]
Mean ± Standard Deviation
  2.45  ± 7.565     4.70  ± 18.784  

No statistical analysis provided for Mean Change From Baseline in Hips Measurement (cm)



68.  Secondary:   Mean Change From Baseline in Mid-Thigh Measurement (cm)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Mid-Thigh Measurement (cm)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  90     84  
Mean Change From Baseline in Mid-Thigh Measurement (cm)  
[units: cm]
Mean ± Standard Deviation
  2.09  ± 21.148     5.13  ± 25.969  

No statistical analysis provided for Mean Change From Baseline in Mid-Thigh Measurement (cm)



69.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)  
[units: grams]
Mean ± Standard Deviation
  7.28  ± 31.953     21.53  ± 52.911  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)



70.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)  
[units: grams]
Mean ± Standard Deviation
  -1.49  ± 7.725     -1.25  ± 10.693  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)



71.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)  
[units: grams]
Mean ± Standard Deviation
  -0.33  ± 9.013     1.52  ± 12.911  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)



72.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)  
[units: grams]
Mean ± Standard Deviation
  15.32  ± 31.250     28.82  ± 49.855  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)



73.  Secondary:   Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)  
[units: grams]
Mean ± Standard Deviation
  1.97  ± 6.220     2.27  ± 8.080  

No statistical analysis provided for Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)



74.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)  
[units: grams]
Mean ± Standard Deviation
  4.32  ± 9.797     6.96  ± 11.466  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)



75.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)  
[units: grams]
Mean ± Standard Deviation
  13.75  ± 40.009     27.01  ± 65.086  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)



76.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)  
[units: grams]
Mean ± Standard Deviation
  1.67  ± 5.988     2.56  ± 7.248  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)



77.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)  
[units: grams]
Mean ± Standard Deviation
  3.48  ± 9.352     6.34  ± 10.122  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)



78.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)  
[units: grams]
Mean ± Standard Deviation
  12.71  ± 33.543     25.31  ± 53.892  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)



79.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)  
[units: grams]
Mean ± Standard Deviation
  1.08  ± 5.224     1.56  ± 6.005  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)



80.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)  
[units: grams]
Mean ± Standard Deviation
  2.9  ± 8.52     5.4  ± 9.42  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)



81.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)  
[units: grams]
Mean ± Standard Deviation
  -3.69  ± 5.224     0.52  ± 5.861  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)



82.  Secondary:   Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)
Measure 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  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who had values at Baseline and Week 96 are included in the analysis.

Reporting Groups
  Description
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

Measured Values
    LPV/r + FTC/TDF     LPV/r + RAL  
Number of Participants Analyzed  
[units: participants]
  82     78  
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)  
[units: grams/cm^2]
Mean ± Standard Deviation
  -2.48  ± 3.797     0.68  ± 4.614  

No statistical analysis provided for Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided by Abbott

Publications automatically indexed to this study:

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00711009     History of Changes
Other Study ID Numbers: M10-336, 2008-000881-22
Study First Received: July 3, 2008
Results First Received: November 16, 2010
Last Updated: February 13, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Italy: The Italian Medicines Agency
Poland: The Central Register of Clinical Trials
Spain: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)