| 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 | 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. | Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | Percentage of Participants | | Baseline to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| | | Title | Denominators | Categories |
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| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| 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). | exact binomial method | | 0.850 | | Diff. in Percentage of Subj. Responding | -1.6 | | | 2-Sided | 95 | -12.0 | 8.8 | | | | Yes | Non-Inferiority or Equivalence | 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. |
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| Primary | Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events | 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. | Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | Percentage of participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| 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 | 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. | Intention to treat analysis of all randomized participants who received at least 1 dose of study drug. | Posted | Oct 2011 | Number | | Percentage of Participants | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Primary | Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values | Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented. | All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value. | Posted | | Number | | Percentage of participants | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit | | 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. | Posted | | Mean | Standard Error | cells/microliter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672 | 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. | Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | Percentage of Participants | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| 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. | 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. | 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. | Posted | | Number | | Participants | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir | 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. | 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. | Posted | | Number | | Participants | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey | 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. | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Error | Scores on a scale | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey | 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. | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Error | Scores on a scale | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM) | 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. | Participants who had values at Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication | 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. | Participants who had values at Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication | 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. | Participants who had values at Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Hemoglobin (Grams/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | grams/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Hematocrit (Fraction) | 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. | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | % by volume of packed RBCs in blood | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | number of cells x 10^12/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Platelet Count (x 10^9/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | number of cells x 10^9/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | number of cells x 10^9/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Neutrophils (x 10^9/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | number of cells x 10^9/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Lymphocytes (x 10^9/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | number of cells x 10^9/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Monocytes (x 10^9/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | number of cells x 10^9/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Eosinophils (x 10^9/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | number of cells x 10^9/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Basophils (x 10^9/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | number of cells x 10^9/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Alanine Aminotransferase (Units/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | units/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | units/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Alkaline Phosphatase (Units/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | units/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Creatine Phosphokinase (Units/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | units/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Total Bilirubin (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Creatinine (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Uric Acid (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Calcium (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Sodium (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Potassium (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Chloride (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Bicarbonate (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Albumin (Grams/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | grams/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Total Protein (Grams/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | grams/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Cholesterol (Micromoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio) | | Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | ratio | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Triglycerides (Micromoles/Liter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micromoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | milliliters/second | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Fasting Glucose (Millimoles/Liter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | millimoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | units/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Lipase (Units/Liter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | units/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Magnesium (Millimoles/Liter) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | millimoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Adiponectin (Micrograms/Milliliter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | micrograms/milliliter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Interleukin-6 (Nanograms/Liter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | nanograms/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Lactate (Millimoles/Liter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | millimoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | picograms/milliliter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | picograms/milliliter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Leptin (Nanograms/Milliliter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | nanograms/milliliter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Insulin (Picomoles/Liter) | Included in measures of metabolic toxicity | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | picomoles/liter | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Urine Specific Gravity | 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. | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | ratio of urine density to water density | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Urine pH | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | pH | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | mm Hg | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | beats per minute | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Weight (kg) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | kg | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Temperature (°F) | | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | °F | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Chest Measurement (cm) | 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. | Participants who had values at Baseline and Week 96 were included in the analysis. | Posted | | Mean | Standard Deviation | cm | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Waist Measurement (cm) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | cm | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Mid-Arm Measurement (cm) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | cm | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Hips Measurement (cm) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | cm | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Mid-Thigh Measurement (cm) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | cm | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
| |
| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams) | 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. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams) | The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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| Secondary | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2) | The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. | Participants who had values at Baseline and Week 96 are included in the analysis. | Posted | | Mean | Standard Deviation | grams/cm^2 | | Baseline to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | LPV/r + FTC/TDF | lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily | | OG001 | LPV/r + RAL | lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily |
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