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

Abbott206 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

206

Conditions

Human Immunodeficiency Virus Infection

Interventions

lopinavir/ritonavir (LPV/r)DRUG

LPV/r 400/100 mg BID

emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)DRUG

FTC/TDF 200/300 mg QD

raltegravir (RAL)DRUG

RAL 400 mg BID

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (37)

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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Site Reference ID/Investigator# 8431

Phoenix, Arizona, United States

Site Reference ID/Investigator# 8432

Beverly Hills, California, United States

Site Reference ID/Investigator# 8394

Atlantis, Florida, United States

Site Reference ID/Investigator# 8393

Ft. Pierce, Florida, United States

Site Reference ID/Investigator# 8425

Orlando, Florida, United States

Site Reference ID/Investigator# 8402

Tampa, Florida, United States

Site Reference ID/Investigator# 8396

Vero Beach, Florida, United States

Site Reference ID/Investigator# 8395

Atlanta, Georgia, United States

Site Reference ID/Investigator# 8429

Decatur, Georgia, United States

Site Reference ID/Investigator# 8424

Boston, Massachusetts, United States

...and 27 more locations

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

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

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

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

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

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

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

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

Mean Change From Baseline in Hemoglobin (Grams/Liter)

Time frame: Baseline to Week 96

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

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

Mean Change From Baseline in Creatinine (Micromoles/Liter)

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

Mean Change From Baseline in Calcium (Micromoles/Liter)

Time frame: Baseline to Week 96

Mean Change From Baseline in Sodium (Micromoles/Liter)

Time frame: Baseline to Week 96

Mean Change From Baseline in Potassium (Micromoles/Liter)

Time frame: Baseline to Week 96

Mean Change From Baseline in Chloride (Micromoles/Liter)

Time frame: Baseline to Week 96

Mean Change From Baseline in Bicarbonate (Micromoles/Liter)

Time frame: Baseline to Week 96

Mean Change From Baseline in Albumin (Grams/Liter)

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

Mean Change From Baseline in Cholesterol (Micromoles/Liter)

Time frame: Baseline to Week 96

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

Mean Change From Baseline in Triglycerides (Micromoles/Liter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

Mean Change From Baseline in Lipase (Units/Liter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Mean Change From Baseline in Magnesium (Millimoles/Liter)

Time frame: Baseline to Week 96

Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

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

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Mean Change From Baseline in Lactate (Millimoles/Liter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

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

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

Mean Change From Baseline in Leptin (Nanograms/Milliliter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

Mean Change From Baseline in Insulin (Picomoles/Liter)

Included in measures of metabolic toxicity

Time frame: Baseline to Week 96

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

Mean Change From Baseline in Urine pH

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

Mean Change From Baseline in Weight (kg)

Time frame: Baseline to Week 96

Mean Change From Baseline in Temperature (°F)

Time frame: Baseline to Week 96

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

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

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

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

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

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

The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

Time frame: Baseline to Week 96

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

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