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

Human Immunodeficiency Virus Infection Clinical Trial

— PROGRESS  

Official title:

A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711009
• Other study ID #: M10-336
• Secondary ID: 2008-000881-22
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2008
• Last updated: February 13, 2012
• Start date: July 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaItaly: The Italian Medicines AgencyPoland: The Central Register of Clinical TrialsSpain: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: October 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must provide written, voluntary informed consent to participate in the study.

• Participants must be naive to antiretroviral treatment with HIV RNA greater than or equal to 1,000 copies/mL at screening, and in the investigator's opinion, require antiretroviral therapy.

• Participant's vital signs, physical examination, and laboratory results must not exhibit evidence of acute illness.

• Participant has not been treated for an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within 45 days of initiating study drug. Participants who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with the Sponsor.

• Participant does not require and agrees not to take any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. Participant agrees not to take any medication during the study, including over-the-counter medicines, vitamins, minerals, herbal preparations, alcohol, or recreational drugs without the knowledge and permission of the principal investigator.

• Female participants must be either postmenopausal for at least one year, surgically sterile, or must use a non-hormonal method of birth control that is acceptable to both the participant and investigator. All female participants must have a urine pregnancy test performed at screening visit and on Day minus 1/baseline, and results of both tests must be negative. Female participants may not be breastfeeding.

• Participants have received no prior treatment with an HIV-1 integrase inhibitor.

Exclusion Criteria:

• Participants must not have history of an allergic reaction or significant sensitivity to the study drugs.

• Participants may not have an ongoing history of substance abuse or psychiatric illness that could preclude protocol adherence.

• Participant cannot have resistance to lopinavir/ritonavir, tenofovir, or emtricitabine based on the HIV-1 drug resistance genotypic test results at the screening visit.

• Participant may not have significant medical history of concomitant illness or disease that would adversely affect his/her participating in the study.

• Participants may not have received any investigational drug or investigational vaccine within 30 days prior to study drug administration.

• Participants may not have any of the following abnormal screening results: Hemoglobin <= 8.0 grams/deciliter, absolute neutrophil count <= 750 cells/microliter, Platelet count <= 50,000 per milliliter, alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) >= 3.0 x upper limit of normal (ULN), calculated creatinine clearance < 50 milliliter/minute, hepatitis B surface antigen (HBsAg) is positive.

• The investigator considers the participant to be an unsuitable candidate for the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus Infection
• Immunologic Deficiency Syndromes
• Virus Diseases

Intervention

Drug:
• lopinavir/ritonavir (LPV/r)
LPV/r 400/100 mg BID
• emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
FTC/TDF 200/300 mg QD
• raltegravir (RAL)
RAL 400 mg BID

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 8099	Montreal	Quebec
Canada	Site Reference ID/Investigator# 7963	Ottawa	Ontario
Canada	Site Reference ID/Investigator# 7831	Toronto	Ontario
Canada	Site Reference ID/Investigator# 7959	Toronto	Ontario
France	Site Reference ID/Investigator# 7695	Lyon Cedex 04
France	Site Reference ID/Investigator# 7960	Montpellier Cedex 5
France	Site Reference ID/Investigator# 7821	Paris
France	Site Reference ID/Investigator# 8063	Paris
Italy	Site Reference ID/Investigator# 8052	Genoa
Italy	Site Reference ID/Investigator# 7789	Milan
Italy	Site Reference ID/Investigator# 8051	Perugia
Italy	Site Reference ID/Investigator# 8050	Rome
Poland	Site Reference ID/Investigator# 8221	Wroclaw
Puerto Rico	Site Reference ID/Investigator# 7713	Bayamon
Puerto Rico	Site Reference ID/Investigator# 7700	Ponce
Spain	Site Reference ID/Investigator# 11102	Barcelona
Spain	Site Reference ID/Investigator# 7689	Barcelona
Spain	Site Reference ID/Investigator# 7697	Barcelona
Spain	Site Reference ID/Investigator# 7692	L'Hospitalet de Llobregat
Spain	Site Reference ID/Investigator# 7691	Madrid
Spain	Site Reference ID/Investigator# 7693	Madrid
Spain	Site Reference ID/Investigator# 7698	Madrid
Spain	Site Reference ID/Investigator# 7690	Seville
United States	Site Reference ID/Investigator# 8395	Atlanta	Georgia
United States	Site Reference ID/Investigator# 8394	Atlantis	Florida
United States	Site Reference ID/Investigator# 8432	Beverly Hills	California
United States	Site Reference ID/Investigator# 8424	Boston	Massachusetts
United States	Site Reference ID/Investigator# 8426	Charlotte	North Carolina
United States	Site Reference ID/Investigator# 8403	Dallas	Texas
United States	Site Reference ID/Investigator# 8429	Decatur	Georgia
United States	Site Reference ID/Investigator# 8393	Fort Pierce	Florida
United States	Site Reference ID/Investigator# 8433	Houston	Texas
United States	Site Reference ID/Investigator# 11461	Huntersville	North Carolina
United States	Site Reference ID/Investigator# 8425	Orlando	Florida
United States	Site Reference ID/Investigator# 8431	Phoenix	Arizona
United States	Site Reference ID/Investigator# 8402	Tampa	Florida
United States	Site Reference ID/Investigator# 8396	Vero Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy,  Poland,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to Week 48	No
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.	Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	No
Secondary	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit		Baseline to Week 96	No
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.	Baseline to Week 96	No
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.	Baseline to Week 96	No
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.	Baseline to Week 96	No
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.	Baseline to Week 96	No
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.	Baseline to Week 96	No
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.	Week 96	No
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.	Week 96	No
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.	Week 96	No
Secondary	Mean Change From Baseline in Hemoglobin (Grams/Liter)		Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Platelet Count (x 10^9/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Neutrophils (x 10^9/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Lymphocytes (x 10^9/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Monocytes (x 10^9/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Eosinophils (x 10^9/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Basophils (x 10^9/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Creatinine (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Uric Acid (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Calcium (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Sodium (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Potassium (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Chloride (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Bicarbonate (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Albumin (Grams/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Total Protein (Grams/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Cholesterol (Micromoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Triglycerides (Micromoles/Liter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Lipase (Units/Liter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Magnesium (Millimoles/Liter)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Lactate (Millimoles/Liter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Leptin (Nanograms/Milliliter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Insulin (Picomoles/Liter)	Included in measures of metabolic toxicity	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Urine pH		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Weight (kg)		Baseline to Week 96	Yes
Secondary	Mean Change From Baseline in Temperature (°F)		Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes
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.	Baseline to Week 96	Yes

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