Primary Outcomes

Measure: Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.

Time: 48 weeks

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Secondary Outcomes

Measure: Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.

Time: 48 weeks

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Measure: CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.

Time: Week 48

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Measure: CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.

Time: Week 48

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Measure: Median Change From Baseline in Triglycerides at Week 48.

Time: Week 48

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Measure: Median Change From Baseline in Total Cholesterol at Week 48.

Time: Week 48

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Measure: Median Change From Baseline in LDL Cholesterol at Week 48.

Time: Week 48

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Measure: Median Change From Baseline in HDL Cholesterol.

Time: Week 48

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Measure: Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.

Time: Week 48

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Measure: Median Change From Baseline in Glucose at Week 48.

Time: Week 48

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Primary Outcomes

Measure: Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24

Time: week 24

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Secondary Outcomes

Measure: Proportions of patients with HIV RNA levels of less than 50 copies/ml at week 48, with HIV RNA levels of less than 400 copies/ml at weeks 24 and 48

Time: week 24 and 48

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Measure: HIV RNA level evolution between baseline and week 48

Time: from week 0 to 48

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Measure: HIV proviral DNA and 2LTR circle HIV DNA between baseline and week 48

Time: from week 0 to 48

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Measure: Number and type of resistance mutations in case of virologic failure occurrence

Time: from week 0 to 48

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Measure: CD4 lymphocyte count and proportion evolution between baseline and week 48

Time: from week 0 to 48

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Measure: HIV infection progression

Time: from week 0 to 48

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Measure: Frequency of the study regimen modifications and interruption

Time: from week 0 to 48

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Measure: Study regimen tolerance

Time: from week 0 to 48

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Measure: Study regimen adherence

Time: from week 0 to 48

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Measure: Association between study drugs' minimum concentrations at week 4 and week 12 and virologic success at week 24

Time: from week 4 to 24

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Measure: Evolution of pharmacokinetics parameters of study drugs in the PK substudy

Time: betwwen week 1 and 4

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Primary Outcomes

Measure: The proportion of subjects with a plasma HIV-1 RNA level below 50 copies/mL at Week 96.

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Secondary Outcomes

Measure: Vital signs

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Measure: Physical examinations

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Measure: Clinical laboratory tests

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Primary Outcomes

Measure: Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL

Time: At Week 48

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Secondary Outcomes

Measure: Proportion of subjects with HIV-1 RNA < 50 c/mL

Time: At week 24

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Measure: Change from baseline in CD4 cell count

Time: Baseline (Week 0) and at week 48

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Measure: Incidence rates of serious adverse event (SAEs) and adverse events (AEs) leading to discontinuation

Time: up to week 48

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Measure: Incidence rates of antiretroviral resistance measured by newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failure

Time: up to week 48

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Measure: Proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 by baseline M184V presence or absence

Time: Week 48

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Primary Outcomes

Description: Undetectable viral load <50 copies/ml according to the FDA snapshot algorithm

Measure: Proportion of patients with undetectable viral load

Time: week 48

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Secondary Outcomes

Description: Undetectable viral load < 50 copies/ml according to the FDA snapshot algorithm

Measure: Proportion of patients with undetectable viral load

Time: Week 24

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Description: Proportion of patients with viral load < 200 copies/ml according to FDA snapshot algorithm

Measure: Proportion of patients with viral load < 200 copies/ml

Time: week 48

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Description: Viral load ≥ 50 copies/ml

Measure: Proportion of patients who present viral load ≥ 50 copies /ml one time

Time: From basal visit until week 48 visit

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Description: Viral load ≥ 50 copies /ml

Measure: Proportion of patients who present viral load ≥ 50 copies /ml more tan two times

Time: From basal visit until week 48 visit

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Description: Viral load < 50 copies/ml

Measure: Proportion of patients who maintained viral load < 50 copies/ml in all determinations

Time: week 48

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Description: CD4/µl

Measure: Median of change cells CD4/µl count from basal to week 48

Time: week 48

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Measure: Median of change in triglycerides , LDL-cholesterol, HDL-cholesterol and total cholesterol from basal to week 48

Time: week 48

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Description: Change in glomerular filtration

Measure: Change in renal function

Time: week 48

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Measure: Change in proportion of patients with renal tubular dysfunction

Time: week 48

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Other Outcomes

Description: Mutations in patients viral failure

Measure: Proportion of genotypic resistance mutations

Time: Week 48

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Measure: Change in proportion of genotypic resistance mutations

Time: week 48

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Primary Outcomes

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.

Measure: 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: Baseline to Week 48

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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.

Measure: Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events

Time: Week 96

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

Measure: Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values

Time: Baseline to Week 96

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Secondary Outcomes

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.

Measure: 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: Baseline to Week 96

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Measure: Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit

Time: Baseline to Week 96

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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.

Measure: Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672

Time: Baseline to Week 96

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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.

Measure: 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: Baseline to Week 96

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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.

Measure: Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir

Time: Baseline to Week 96

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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.

Measure: Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey

Time: Baseline to Week 96

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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.

Measure: Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey

Time: Baseline to Week 96

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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.

Measure: Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)

Time: Week 96

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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.

Measure: Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication

Time: Week 96

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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.

Measure: Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication

Time: Week 96

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Measure: Mean Change From Baseline in Hemoglobin (Grams/Liter)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Hematocrit (Fraction)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Platelet Count (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Neutrophils (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Lymphocytes (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Monocytes (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Eosinophils (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Basophils (x 10^9/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Creatinine (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Uric Acid (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Calcium (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Sodium (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Potassium (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Chloride (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Bicarbonate (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Albumin (Grams/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Total Protein (Grams/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Cholesterol (Micromoles/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Triglycerides (Micromoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Lipase (Units/Liter)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Magnesium (Millimoles/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Lactate (Millimoles/Liter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Leptin (Nanograms/Milliliter)

Time: Baseline to Week 96

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Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Insulin (Picomoles/Liter)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Urine Specific Gravity

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Urine pH

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Weight (kg)

Time: Baseline to Week 96

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Measure: Mean Change From Baseline in Temperature (°F)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Chest Measurement (cm)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Waist Measurement (cm)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Mid-Arm Measurement (cm)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Hips Measurement (cm)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Mid-Thigh Measurement (cm)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)

Time: Baseline to Week 96

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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.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)

Time: Baseline to Week 96

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

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)

Time: Baseline to Week 96

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

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)

Time: Baseline to Week 96

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