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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00711009

Acronym

PROGRESS

Enrollment

206

Registered

2008-07-08

Start date

2008-07-31

Completion date

2010-10-31

Last updated

2012-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus Infection

Keywords

Human Immunodeficiency Virus infection

Brief 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.

Interventions

DRUGlopinavir/ritonavir (LPV/r)

LPV/r 400/100 mg BID

DRUGemtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

FTC/TDF 200/300 mg QD

DRUGraltegravir (RAL)

RAL 400 mg BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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	Baseline to Week 48	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.
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Week 96	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.
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Baseline to Week 96	Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.

Secondary

Measure	Time frame	Description
Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672	Baseline to Week 96	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.
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.	Baseline to Week 96	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.
Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir	Baseline to Week 96	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.
Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey	Baseline to Week 96	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.
Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey	Baseline to Week 96	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.
Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)	Week 96	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.
Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication	Week 96	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.
Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication	Week 96	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.
Mean Change From Baseline in Hemoglobin (Grams/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Hematocrit (Fraction)	Baseline to Week 96	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.
Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Platelet Count (x 10^9/Liter)	Baseline to Week 96	—
Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Neutrophils (x 10^9/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Lymphocytes (x 10^9/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Monocytes (x 10^9/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Eosinophils (x 10^9/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Creatinine (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Uric Acid (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Calcium (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Sodium (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Potassium (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Chloride (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Bicarbonate (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Albumin (Grams/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Total Protein (Grams/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Cholesterol (Micromoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)	Baseline to Week 96	—
Mean Change From Baseline in Triglycerides (Micromoles/Liter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)	Baseline to Week 96	—
Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Lipase (Units/Liter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Magnesium (Millimoles/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Lactate (Millimoles/Liter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Leptin (Nanograms/Milliliter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Insulin (Picomoles/Liter)	Baseline to Week 96	Included in measures of metabolic toxicity
Mean Change From Baseline in Urine Specific Gravity	Baseline to Week 96	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.
Mean Change From Baseline in Urine pH	Baseline to Week 96	—
Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)	Baseline to Week 96	—
Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)	Baseline to Week 96	—
Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)	Baseline to Week 96	—
Mean Change From Baseline in Weight (kg)	Baseline to Week 96	—
Mean Change From Baseline in Temperature (°F)	Baseline to Week 96	—
Mean Change From Baseline in Chest Measurement (cm)	Baseline to Week 96	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.
Mean Change From Baseline in Waist Measurement (cm)	Baseline to Week 96	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.
Mean Change From Baseline in Mid-Arm Measurement (cm)	Baseline to Week 96	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.
Mean Change From Baseline in Hips Measurement (cm)	Baseline to Week 96	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.
Mean Change From Baseline in Mid-Thigh Measurement (cm)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Basophils (x 10^9/Liter)	Baseline to Week 96	—
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)	Baseline to Week 96	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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)	Baseline to Week 96	The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)	Baseline to Week 96	The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)	Baseline to Week 96	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.
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Baseline to Week 96	—
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	Baseline to Week 96	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.

Countries

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

Participant flow

Pre-assignment details

3 additional participants were randomized but did not receive study drug and therefore were not included in the analyses.

Participants by arm

Arm	Count
LPV/r + FTC/TDF lopinavir/ritonavir 400/100 mg tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily	105
LPV/r + RAL lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily	101
Total	206

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event/HIV-Related Event	4	5
Overall Study	Dose adjustment	1	0
Overall Study	Lost to Follow-up	3	9
Overall Study	Participant Noncompliant	0	1
Overall Study	Pregnancy	1	0
Overall Study	Site closing	0	1
Overall Study	Virologic Failure	2	1
Overall Study	Withdrawal by Subject	4	2

Baseline characteristics

Characteristic	LPV/r + RAL	Total	LPV/r + FTC/TDF
Age Continuous	39.8 years STANDARD_DEVIATION 9.94	39.6 years STANDARD_DEVIATION 10.6	39.4 years STANDARD_DEVIATION 11.24
CD4+ T-Cell Counts	289.3 cells/microliter STANDARD_DEVIATION 149.03	293.5 cells/microliter STANDARD_DEVIATION 157.93	297.6 cells/microliter STANDARD_DEVIATION 166.66
Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Level	4.2 log10 copies/milliliter STANDARD_DEVIATION 0.83	4.2 log10 copies/milliliter STANDARD_DEVIATION 0.79	4.3 log10 copies/milliliter STANDARD_DEVIATION 0.76
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants	0 participants	0 participants
Race/Ethnicity, Customized Asian	3 participants	4 participants	1 participants
Race/Ethnicity, Customized Black or African American	22 participants	44 participants	22 participants
Race/Ethnicity, Customized More than one race	1 participants	1 participants	0 participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants	0 participants	0 participants
Race/Ethnicity, Customized Other	1 participants	2 participants	1 participants
Race/Ethnicity, Customized Unknown or Not Reported	0 participants	0 participants	0 participants
Race/Ethnicity, Customized White	74 participants	155 participants	81 participants
Region of Enrollment Europe	42 participants	86 participants	44 participants
Region of Enrollment North America	59 participants	120 participants	61 participants
Sex: Female, Male Female	13 Participants	32 Participants	19 Participants
Sex: Female, Male Male	88 Participants	174 Participants	86 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	96 / 105	94 / 101
serious Total, serious adverse events	14 / 105	12 / 101

Outcome results

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.

Time frame: Baseline to Week 48

Population: Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.

Arm	Measure	Value (NUMBER)
LPV/r + FTC/TDF	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	84.8 Percentage of Participants
LPV/r + RAL	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	83.2 Percentage of Participants

Comparison: 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).p-value: 0.8595% CI: [-12, 8.8]exact binomial method

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.

Time frame: Week 96

Population: Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.

Arm	Measure	Group	Value (NUMBER)
LPV/r + FTC/TDF	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Diarrhoea	16.2 Percentage of participants
LPV/r + FTC/TDF	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Blood triglycerides increased	1.9 Percentage of participants
LPV/r + FTC/TDF	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Hypertriglyceridaemia	2.9 Percentage of participants
LPV/r + FTC/TDF	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Alanine aminotransferase increased	1.0 Percentage of participants
LPV/r + FTC/TDF	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Hyperchloresterolaemia	4.8 Percentage of participants
LPV/r + FTC/TDF	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Aspartate aminotransferase increased	0 Percentage of participants
LPV/r + FTC/TDF	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Hyperlipidaemia	1.0 Percentage of participants
LPV/r + FTC/TDF	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Asthenia	2.9 Percentage of participants
LPV/r + FTC/TDF	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Any adverse event	34.3 Percentage of participants
LPV/r + RAL	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Asthenia	0 Percentage of participants
LPV/r + RAL	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Any adverse event	30.7 Percentage of participants
LPV/r + RAL	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Diarrhoea	7.9 Percentage of participants
LPV/r + RAL	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Hyperchloresterolaemia	8.9 Percentage of participants
LPV/r + RAL	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Hypertriglyceridaemia	5.9 Percentage of participants
LPV/r + RAL	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Hyperlipidaemia	3.0 Percentage of participants
LPV/r + RAL	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Blood triglycerides increased	3.0 Percentage of participants
LPV/r + RAL	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Alanine aminotransferase increased	3.0 Percentage of participants
LPV/r + RAL	Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events	Aspartate aminotransferase increased	2.0 Percentage of participants

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.

Time frame: Baseline to Week 96

Population: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline laboratory value.

Arm	Measure	Group	Value (NUMBER)
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Alananine aminotransferase >5x upper limit normal	2.9 Percentage of participants
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Aspartate aminotransferase >5x upper limit normal	2.9 Percentage of participants
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Creatinine phosphokinase >4x upper limit of normal	8.7 Percentage of participants
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Calcium <1.75 millimoles/liter	0 Percentage of participants
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Cholesterol >7.77 millimoles/liter	13.5 Percentage of participants
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Triglycerides >8.475 millimoles/liter	4.8 Percentage of participants
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Calc. creatinine clearance <50 milliliters/minute	3.8 Percentage of participants
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Lipase >2x upper limit of normal	7.7 Percentage of participants
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Neutrophils < 0.75 x 10^9/liter	3.8 Percentage of participants
LPV/r + FTC/TDF	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Magnesium < 0.5 millimoles/liter	0 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Lipase >2x upper limit of normal	4.0 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Alananine aminotransferase >5x upper limit normal	5.0 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Triglycerides >8.475 millimoles/liter	9.9 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Aspartate aminotransferase >5x upper limit normal	5.0 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Magnesium < 0.5 millimoles/liter	2.0 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Creatinine phosphokinase >4x upper limit of normal	19.8 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Calc. creatinine clearance <50 milliliters/minute	1.0 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Calcium <1.75 millimoles/liter	2.0 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Neutrophils < 0.75 x 10^9/liter	0 Percentage of participants
LPV/r + RAL	Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values	Cholesterol >7.77 millimoles/liter	16.8 Percentage of participants

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey	1.3 Scores on a scale	Standard Error 1.44
LPV/r + RAL	Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey	1.3 Scores on a scale	Standard Error 1.62

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey	-1.0 Scores on a scale	Standard Error 1.34
LPV/r + RAL	Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey	-1.1 Scores on a scale	Standard Error 1.51

Secondary

Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)	2.112 micrograms/milliliter	Standard Deviation 7.36
LPV/r + RAL	Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)	2.064 micrograms/milliliter	Standard Deviation 4.997

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)	-6.1 units/liter	Standard Deviation 41.45
LPV/r + RAL	Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)	-13.4 units/liter	Standard Deviation 39.96

Secondary

Mean Change From Baseline in Albumin (Grams/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Albumin (Grams/Liter)	1.4 grams/liter	Standard Deviation 3.48
LPV/r + RAL	Mean Change From Baseline in Albumin (Grams/Liter)	1.3 grams/liter	Standard Deviation 3.66

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)	14.5 units/liter	Standard Deviation 20.26
LPV/r + RAL	Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)	1.7 units/liter	Standard Deviation 24.53

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)	-0.8 units/liter	Standard Deviation 64.29
LPV/r + RAL	Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)	-9.6 units/liter	Standard Deviation 37.86

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Basophils (x 10^9/Liter)	0.005 number of cells x 10^9/liter	Standard Deviation 0.0233
LPV/r + RAL	Mean Change From Baseline in Basophils (x 10^9/Liter)	0.003 number of cells x 10^9/liter	Standard Deviation 0.0222

Secondary

Mean Change From Baseline in Bicarbonate (Micromoles/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Bicarbonate (Micromoles/Liter)	-0.5 micromoles/liter	Standard Deviation 2.79
LPV/r + RAL	Mean Change From Baseline in Bicarbonate (Micromoles/Liter)	-0.8 micromoles/liter	Standard Deviation 3.28

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)	0.00 micromoles/liter	Standard Deviation 1.39
LPV/r + RAL	Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)	0.37 micromoles/liter	Standard Deviation 1.658

Secondary

Mean Change From Baseline in Calcium (Micromoles/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Calcium (Micromoles/Liter)	-0.040 micromoles/liter	Standard Deviation 0.1071
LPV/r + RAL	Mean Change From Baseline in Calcium (Micromoles/Liter)	-0.016 micromoles/liter	Standard Deviation 0.1468

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)	-0.122 milliliters/second	Standard Deviation 0.3047
LPV/r + RAL	Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)	-0.024 milliliters/second	Standard Deviation 0.302

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Chest Measurement (cm)	1.13 cm	Standard Deviation 6.01
LPV/r + RAL	Mean Change From Baseline in Chest Measurement (cm)	4.06 cm	Standard Deviation 18.903

Secondary

Mean Change From Baseline in Chloride (Micromoles/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Chloride (Micromoles/Liter)	-0.4 micromoles/liter	Standard Deviation 2.51
LPV/r + RAL	Mean Change From Baseline in Chloride (Micromoles/Liter)	0.2 micromoles/liter	Standard Deviation 3.65

Secondary

Mean Change From Baseline in Cholesterol (Micromoles/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Cholesterol (Micromoles/Liter)	0.808 micromoles/liter	Standard Deviation 1.0327
LPV/r + RAL	Mean Change From Baseline in Cholesterol (Micromoles/Liter)	1.113 micromoles/liter	Standard Deviation 1.1699

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)	398.9 units/liter	Standard Deviation 3381.1
LPV/r + RAL	Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)	157.2 units/liter	Standard Deviation 1081.24

Secondary

Mean Change From Baseline in Creatinine (Micromoles/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Creatinine (Micromoles/Liter)	5.7 micromoles/liter	Standard Deviation 12.66
LPV/r + RAL	Mean Change From Baseline in Creatinine (Micromoles/Liter)	1.6 micromoles/liter	Standard Deviation 11.54

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)	1.97 grams	Standard Deviation 6.22
LPV/r + RAL	Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)	2.27 grams	Standard Deviation 8.08

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)	-3.69 grams	Standard Deviation 5.224
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)	0.52 grams	Standard Deviation 5.861

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)	-2.48 grams/cm^2	Standard Deviation 3.797
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)	0.68 grams/cm^2	Standard Deviation 4.614

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)	15.32 grams	Standard Deviation 31.25
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)	28.82 grams	Standard Deviation 49.855

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)	4.32 grams	Standard Deviation 9.797
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)	6.96 grams	Standard Deviation 11.466

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)	12.71 grams	Standard Deviation 33.543
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)	25.31 grams	Standard Deviation 53.892

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)	1.08 grams	Standard Deviation 5.224
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)	1.56 grams	Standard Deviation 6.005

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)	2.9 grams	Standard Deviation 8.52
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)	5.4 grams	Standard Deviation 9.42

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)	13.75 grams	Standard Deviation 40.009
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)	27.01 grams	Standard Deviation 65.086

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)	1.67 grams	Standard Deviation 5.988
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)	2.56 grams	Standard Deviation 7.248

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)	3.48 grams	Standard Deviation 9.352
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)	6.34 grams	Standard Deviation 10.122

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)	7.28 grams	Standard Deviation 31.953
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)	21.53 grams	Standard Deviation 52.911

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)	-1.49 grams	Standard Deviation 7.725
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)	-1.25 grams	Standard Deviation 10.693

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)	-0.33 grams	Standard Deviation 9.013
LPV/r + RAL	Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)	1.52 grams	Standard Deviation 12.911

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Eosinophils (x 10^9/Liter)	-0.012 number of cells x 10^9/liter	Standard Deviation 0.0817
LPV/r + RAL	Mean Change From Baseline in Eosinophils (x 10^9/Liter)	0.015 number of cells x 10^9/liter	Standard Deviation 0.1063

Secondary

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)	-0.011 millimoles/liter	Standard Deviation 0.7501
LPV/r + RAL	Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)	0.109 millimoles/liter	Standard Deviation 1.1172

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Hematocrit (Fraction)	0.038 % by volume of packed RBCs in blood	Standard Deviation 0.0379
LPV/r + RAL	Mean Change From Baseline in Hematocrit (Fraction)	0.036 % by volume of packed RBCs in blood	Standard Deviation 0.0386

Secondary

Mean Change From Baseline in Hemoglobin (Grams/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Hemoglobin (Grams/Liter)	5.4 grams/liter	Standard Deviation 13.26
LPV/r + RAL	Mean Change From Baseline in Hemoglobin (Grams/Liter)	5.1 grams/liter	Standard Deviation 13.05

Secondary

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)	0.257 micromoles/liter	Standard Deviation 0.306
LPV/r + RAL	Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)	0.346 micromoles/liter	Standard Deviation 0.3162

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Hips Measurement (cm)	2.45 cm	Standard Deviation 7.565
LPV/r + RAL	Mean Change From Baseline in Hips Measurement (cm)	4.70 cm	Standard Deviation 18.784

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)	-0.046 micromoles/liter	Standard Deviation 0.1645
LPV/r + RAL	Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)	-0.028 micromoles/liter	Standard Deviation 0.2391

Secondary

Mean Change From Baseline in Insulin (Picomoles/Liter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Insulin (Picomoles/Liter)	-6.724 picomoles/liter	Standard Deviation 49.2087
LPV/r + RAL	Mean Change From Baseline in Insulin (Picomoles/Liter)	4.441 picomoles/liter	Standard Deviation 72.8859

Secondary

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)	-1.584 nanograms/liter	Standard Deviation 9.4362
LPV/r + RAL	Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)	-53.286 nanograms/liter	Standard Deviation 422.1502

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)	-21.157 units/liter	Standard Deviation 69.292
LPV/r + RAL	Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)	-28.926 units/liter	Standard Deviation 41.4161

Secondary

Mean Change From Baseline in Lactate (Millimoles/Liter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Lactate (Millimoles/Liter)	0.281 millimoles/liter	Standard Deviation 0.6456
LPV/r + RAL	Mean Change From Baseline in Lactate (Millimoles/Liter)	0.444 millimoles/liter	Standard Deviation 1.2115

Secondary

Mean Change From Baseline in Leptin (Nanograms/Milliliter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Leptin (Nanograms/Milliliter)	3.623 nanograms/milliliter	Standard Deviation 7.3797
LPV/r + RAL	Mean Change From Baseline in Leptin (Nanograms/Milliliter)	2.927 nanograms/milliliter	Standard Deviation 6.442

Secondary

Mean Change From Baseline in Lipase (Units/Liter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Lipase (Units/Liter)	4.674 units/liter	Standard Deviation 54.337
LPV/r + RAL	Mean Change From Baseline in Lipase (Units/Liter)	-1.898 units/liter	Standard Deviation 24.5716

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values for both measures (LDL and HDL) at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)	-0.056 ratio	Standard Deviation 0.7798
LPV/r + RAL	Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)	-0.040 ratio	Standard Deviation 0.9119

Secondary

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)	0.535 micromoles/liter	Standard Deviation 0.8583
LPV/r + RAL	Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)	0.715 micromoles/liter	Standard Deviation 0.9831

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Lymphocytes (x 10^9/Liter)	0.332 number of cells x 10^9/liter	Standard Deviation 0.6901
LPV/r + RAL	Mean Change From Baseline in Lymphocytes (x 10^9/Liter)	0.368 number of cells x 10^9/liter	Standard Deviation 0.8068

Secondary

Mean Change From Baseline in Magnesium (Millimoles/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Magnesium (Millimoles/Liter)	0.019 millimoles/liter	Standard Deviation 0.0748
LPV/r + RAL	Mean Change From Baseline in Magnesium (Millimoles/Liter)	-0.009 millimoles/liter	Standard Deviation 0.0763

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Mid-Arm Measurement (cm)	1.76 cm	Standard Deviation 19.688
LPV/r + RAL	Mean Change From Baseline in Mid-Arm Measurement (cm)	4.71 cm	Standard Deviation 20.844

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Mid-Thigh Measurement (cm)	2.09 cm	Standard Deviation 21.148
LPV/r + RAL	Mean Change From Baseline in Mid-Thigh Measurement (cm)	5.13 cm	Standard Deviation 25.969

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Monocytes (x 10^9/Liter)	0.065 number of cells x 10^9/liter	Standard Deviation 0.1435
LPV/r + RAL	Mean Change From Baseline in Monocytes (x 10^9/Liter)	0.112 number of cells x 10^9/liter	Standard Deviation 0.1436

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Neutrophils (x 10^9/Liter)	0.509 number of cells x 10^9/liter	Standard Deviation 1.2256
LPV/r + RAL	Mean Change From Baseline in Neutrophils (x 10^9/Liter)	0.705 number of cells x 10^9/liter	Standard Deviation 1.2836

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Platelet Count (x 10^9/Liter)	46.8 number of cells x 10^9/liter	Standard Deviation 69.18
LPV/r + RAL	Mean Change From Baseline in Platelet Count (x 10^9/Liter)	34.2 number of cells x 10^9/liter	Standard Deviation 68.94

Secondary

Mean Change From Baseline in Potassium (Micromoles/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Potassium (Micromoles/Liter)	0.13 micromoles/liter	Standard Deviation 0.386
LPV/r + RAL	Mean Change From Baseline in Potassium (Micromoles/Liter)	0.03 micromoles/liter	Standard Deviation 0.386

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)	0.12 number of cells x 10^12/liter	Standard Deviation 0.45
LPV/r + RAL	Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)	0.16 number of cells x 10^12/liter	Standard Deviation 0.471

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)	-2.4 mm Hg	Standard Deviation 9.96
LPV/r + RAL	Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)	-1.8 mm Hg	Standard Deviation 10.56

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)	-4.6 beats per minute	Standard Deviation 13.3
LPV/r + RAL	Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)	-6.3 beats per minute	Standard Deviation 13.72

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)	-0.7 mm Hg	Standard Deviation 16.45
LPV/r + RAL	Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)	-2.4 mm Hg	Standard Deviation 15.2

Secondary

Mean Change From Baseline in Sodium (Micromoles/Liter)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Sodium (Micromoles/Liter)	0.1 micromoles/liter	Standard Deviation 2.04
LPV/r + RAL	Mean Change From Baseline in Sodium (Micromoles/Liter)	0.7 micromoles/liter	Standard Deviation 2.49

Secondary

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)	-138.602 picograms/milliliter	Standard Deviation 362.1327
LPV/r + RAL	Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)	-166.403 picograms/milliliter	Standard Deviation 482.2808

Secondary

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)	-1257.9 picograms/milliliter	Standard Deviation 1354.75
LPV/r + RAL	Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)	-1594.7 picograms/milliliter	Standard Deviation 1682.78

Secondary

Mean Change From Baseline in Temperature (°F)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Temperature (°F)	-0.152 °F	Standard Deviation 0.8069
LPV/r + RAL	Mean Change From Baseline in Temperature (°F)	-0.183 °F	Standard Deviation 0.8768

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)	0.9 micromoles/liter	Standard Deviation 4.17
LPV/r + RAL	Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)	1.9 micromoles/liter	Standard Deviation 6.16

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Total Protein (Grams/Liter)	-6.3 grams/liter	Standard Deviation 6.07
LPV/r + RAL	Mean Change From Baseline in Total Protein (Grams/Liter)	-7.2 grams/liter	Standard Deviation 6.8

Secondary

Mean Change From Baseline in Triglycerides (Micromoles/Liter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Triglycerides (Micromoles/Liter)	0.846 micromoles/liter	Standard Deviation 1.5874
LPV/r + RAL	Mean Change From Baseline in Triglycerides (Micromoles/Liter)	1.103 micromoles/liter	Standard Deviation 1.6805

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Uric Acid (Micromoles/Liter)	-29.0 micromoles/liter	Standard Deviation 65.25
LPV/r + RAL	Mean Change From Baseline in Uric Acid (Micromoles/Liter)	-6.1 micromoles/liter	Standard Deviation 66.29

Secondary

Mean Change From Baseline in Urine pH

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Urine pH	0.00 pH	Standard Deviation 0.672
LPV/r + RAL	Mean Change From Baseline in Urine pH	0.03 pH	Standard Deviation 0.819

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Urine Specific Gravity	0.0042 ratio of urine density to water density	Standard Deviation 0.00742
LPV/r + RAL	Mean Change From Baseline in Urine Specific Gravity	0.0052 ratio of urine density to water density	Standard Deviation 0.00746

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.

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 are included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Waist Measurement (cm)	1.88 cm	Standard Deviation 8.489
LPV/r + RAL	Mean Change From Baseline in Waist Measurement (cm)	4.93 cm	Standard Deviation 20.344

Secondary

Mean Change From Baseline in Weight (kg)

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in Weight (kg)	1.83 kg	Standard Deviation 7.106
LPV/r + RAL	Mean Change From Baseline in Weight (kg)	3.77 kg	Standard Deviation 6.781

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)	0.90 number of cells x 10^9/liter	Standard Deviation 1.717
LPV/r + RAL	Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)	1.20 number of cells x 10^9/liter	Standard Deviation 1.67

Secondary

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

Time frame: Baseline to Week 96

Population: Participants who had values at Baseline and the visit were included in the analysis of data at that visit. Number of participants in each visit analysis ranged from 98 and 96 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 8, to 80 and 76 participants in the LPV/r+FTC/TDF and LPV/r+RAL groups, respectively, at Week 96.

Arm	Measure	Group	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 4	97.2 cells/microliter	Standard Error 10.94
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 48	245.0 cells/microliter	Standard Error 18.02
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 24	154.9 cells/microliter	Standard Error 13.76
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 60	243.4 cells/microliter	Standard Error 18.05
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 8	107.9 cells/microliter	Standard Error 12.07
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 72	277.4 cells/microliter	Standard Error 20.1
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 32	180.0 cells/microliter	Standard Error 13.42
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 84	309.6 cells/microliter	Standard Error 19.83
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 16	158.7 cells/microliter	Standard Error 13.94
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 96	296.4 cells/microliter	Standard Error 20.38
LPV/r + FTC/TDF	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 40	204.6 cells/microliter	Standard Error 15.22
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 96	281.0 cells/microliter	Standard Error 20.91
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 4	113.4 cells/microliter	Standard Error 10.83
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 16	141.6 cells/microliter	Standard Error 14.01
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 24	174.5 cells/microliter	Standard Error 13.99
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 32	188.2 cells/microliter	Standard Error 13.49
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 40	223.0 cells/microliter	Standard Error 15.55
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 48	241.9 cells/microliter	Standard Error 17.83
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 60	250.6 cells/microliter	Standard Error 18.45
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 72	269.9 cells/microliter	Standard Error 20.47
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 84	280.2 cells/microliter	Standard Error 21.05
LPV/r + RAL	Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit	Week 8	124.5 cells/microliter	Standard Error 12.2

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.

Time frame: Baseline to Week 96

Population: The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from \<40 copies/mL to \>=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.

Arm	Measure	Value (NUMBER)
LPV/r + FTC/TDF	Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir	0 Participants
LPV/r + RAL	Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir	1 Participants

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.

Time frame: Baseline to Week 96

Population: The population for each group was the number of participants who met the criteria for resistance testing, that is, participants whose HIV-RNA increased from \<40 copies/ml to \>=40 copies/mL at a later visit and who underwent additional genotyping for resistance to one of the study drugs the participant was receiving.

Arm	Measure	Group	Value (NUMBER)
LPV/r + FTC/TDF	Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.	Lopinavir resistance	0 Participants
LPV/r + FTC/TDF	Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.	Tenofovir resistance	0 Participants
LPV/r + FTC/TDF	Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.	Emtricitabine resistance	1 Participants
LPV/r + FTC/TDF	Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.	Raltegravir resistance	NA Participants
LPV/r + RAL	Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.	Raltegravir resistance	3 Participants
LPV/r + RAL	Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.	Lopinavir resistance	0 Participants
LPV/r + RAL	Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.	Emtricitabine resistance	0 Participants
LPV/r + RAL	Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.	Tenofovir resistance	0 Participants

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.

Time frame: Baseline to Week 96

Population: Intention to treat analysis of all randomized participants who received at least 1 dose of study drug.

Arm	Measure	Group	Value (NUMBER)
LPV/r + FTC/TDF	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	Week 2	7.6 Percentage of Participants
LPV/r + FTC/TDF	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	Week 4	17.1 Percentage of Participants
LPV/r + FTC/TDF	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	Week 8	36.2 Percentage of Participants
LPV/r + FTC/TDF	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	Week 16	67.6 Percentage of Participants
LPV/r + FTC/TDF	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	Week 24	80.0 Percentage of Participants
LPV/r + FTC/TDF	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	Week 32	85.7 Percentage of Participants
LPV/r + FTC/TDF	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	Week 40	84.8 Percentage of Participants
LPV/r + FTC/TDF	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	Week 48	84.8 Percentage of Participants
LPV/r + FTC/TDF	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	Week 60	82.9 Percentage of Participants
LPV/r + FTC/TDF	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	Week 72	78.1 Percentage of Participants
LPV/r + FTC/TDF	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	Week 84	74.3 Percentage of Participants
LPV/r + FTC/TDF	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	Week 96	68.6 Percentage of Participants
LPV/r + RAL	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	Week 84	70.3 Percentage of Participants
LPV/r + RAL	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	Week 2	33.7 Percentage of Participants
LPV/r + RAL	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	Week 40	87.1 Percentage of Participants
LPV/r + RAL	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	Week 4	63.4 Percentage of Participants
LPV/r + RAL	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	Week 72	71.3 Percentage of Participants
LPV/r + RAL	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	Week 8	75.2 Percentage of Participants
LPV/r + RAL	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	Week 48	83.2 Percentage of Participants
LPV/r + RAL	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	Week 16	81.2 Percentage of Participants
LPV/r + RAL	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	Week 96	66.3 Percentage of Participants
LPV/r + RAL	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	Week 24	83.2 Percentage of Participants
LPV/r + RAL	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	Week 60	75.2 Percentage of Participants
LPV/r + RAL	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	Week 32	85.1 Percentage of Participants

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.

Time frame: Week 96

Population: Participants who had values at Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)	75.5 Scores on a scale	Standard Deviation 23.29
LPV/r + RAL	Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)	76.0 Scores on a scale	Standard Deviation 27.47

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.

Time frame: Week 96

Population: Participants who had values at Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication	82.5 Scores on a scale	Standard Deviation 15.49
LPV/r + RAL	Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication	85.5 Scores on a scale	Standard Deviation 15.62

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.

Time frame: Week 96

Population: Participants who had values at Week 96 were included in the analysis.

Arm	Measure	Value (MEAN)	Dispersion
LPV/r + FTC/TDF	Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication	84.6 Scores on a scale	Standard Deviation 17.56
LPV/r + RAL	Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication	86.2 Scores on a scale	Standard Deviation 19.15

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.

Time frame: Baseline to Week 96

Population: Intent to treat (ITT) population, defined as all randomized participants who received at least 1 dose of study drug.

Arm	Measure	Value (NUMBER)
LPV/r + FTC/TDF	Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672	79.1 Percentage of Participants
LPV/r + RAL	Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672	77.8 Percentage of Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

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

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

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

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

Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)

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

Mean Change From Baseline in Albumin (Grams/Liter)

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

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

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

Mean Change From Baseline in Bicarbonate (Micromoles/Liter)

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

Mean Change From Baseline in Calcium (Micromoles/Liter)

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

Mean Change From Baseline in Chest Measurement (cm)

Mean Change From Baseline in Chloride (Micromoles/Liter)

Mean Change From Baseline in Cholesterol (Micromoles/Liter)

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

Mean Change From Baseline in Creatinine (Micromoles/Liter)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Mean Change From Baseline in Hematocrit (Fraction)

Mean Change From Baseline in Hemoglobin (Grams/Liter)

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

Mean Change From Baseline in Hips Measurement (cm)

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

Mean Change From Baseline in Insulin (Picomoles/Liter)

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

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

Mean Change From Baseline in Lactate (Millimoles/Liter)

Mean Change From Baseline in Leptin (Nanograms/Milliliter)

Mean Change From Baseline in Lipase (Units/Liter)

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

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

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

Mean Change From Baseline in Magnesium (Millimoles/Liter)

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

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

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

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

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

Mean Change From Baseline in Potassium (Micromoles/Liter)

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