Back to resultsStudy Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL) (PROGRESS)
Primary Purpose
Human Immunodeficiency Virus Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lopinavir/ritonavir (LPV/r)
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
raltegravir (RAL)
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus Infection focused on measuring Human Immunodeficiency Virus infection
Eligibility Criteria
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.
Sites / Locations
- Site Reference ID/Investigator# 8431
- Site Reference ID/Investigator# 8432
- Site Reference ID/Investigator# 8394
- Site Reference ID/Investigator# 8393
- Site Reference ID/Investigator# 8425
- Site Reference ID/Investigator# 8402
- Site Reference ID/Investigator# 8396
- Site Reference ID/Investigator# 8395
- Site Reference ID/Investigator# 8429
- Site Reference ID/Investigator# 8424
- Site Reference ID/Investigator# 8426
- Site Reference ID/Investigator# 11461
- Site Reference ID/Investigator# 8403
- Site Reference ID/Investigator# 8433
- Site Reference ID/Investigator# 7963
- Site Reference ID/Investigator# 7831
- Site Reference ID/Investigator# 7959
- Site Reference ID/Investigator# 8099
- Site Reference ID/Investigator# 7695
- Site Reference ID/Investigator# 7960
- Site Reference ID/Investigator# 8063
- Site Reference ID/Investigator# 7821
- Site Reference ID/Investigator# 8052
- Site Reference ID/Investigator# 7789
- Site Reference ID/Investigator# 8051
- Site Reference ID/Investigator# 8050
- Site Reference ID/Investigator# 8221
- Site Reference ID/Investigator# 7713
- Site Reference ID/Investigator# 7700
- Site Reference ID/Investigator# 11102
- Site Reference ID/Investigator# 7697
- Site Reference ID/Investigator# 7689
- Site Reference ID/Investigator# 7692
- Site Reference ID/Investigator# 7698
- Site Reference ID/Investigator# 7693
- Site Reference ID/Investigator# 7691
- Site Reference ID/Investigator# 7690
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
LPV/r + FTC/TDF
LPV/r + RAL
Arm Description
lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
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.
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.
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.
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.
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.
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.
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.
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.
Mean Change From Baseline in Hemoglobin (Grams/Liter)
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.
Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
Mean Change From Baseline in Platelet Count (x 10^9/Liter)
Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
Mean Change From Baseline in Neutrophils (x 10^9/Liter)
Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
Mean Change From Baseline in Monocytes (x 10^9/Liter)
Mean Change From Baseline in Eosinophils (x 10^9/Liter)
Mean Change From Baseline in Basophils (x 10^9/Liter)
Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
Mean Change From Baseline in Creatinine (Micromoles/Liter)
Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
Mean Change From Baseline in Uric Acid (Micromoles/Liter)
Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
Mean Change From Baseline in Calcium (Micromoles/Liter)
Mean Change From Baseline in Sodium (Micromoles/Liter)
Mean Change From Baseline in Potassium (Micromoles/Liter)
Mean Change From Baseline in Chloride (Micromoles/Liter)
Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
Mean Change From Baseline in Albumin (Grams/Liter)
Mean Change From Baseline in Total Protein (Grams/Liter)
Mean Change From Baseline in Cholesterol (Micromoles/Liter)
Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
Mean Change From Baseline in Triglycerides (Micromoles/Liter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)
Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)
Mean Change From Baseline in Lipase (Units/Liter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Magnesium (Millimoles/Liter)
Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Lactate (Millimoles/Liter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Leptin (Nanograms/Milliliter)
Included in measures of metabolic toxicity
Mean Change From Baseline in Insulin (Picomoles/Liter)
Included in measures of metabolic toxicity
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.
Mean Change From Baseline in Urine pH
Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)
Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)
Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)
Mean Change From Baseline in Weight (kg)
Mean Change From Baseline in Temperature (°F)
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.
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.
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.
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.
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.
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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
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.
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.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
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.
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.
Full Information
NCT ID
NCT00711009
First Posted
July 3, 2008
Last Updated
February 13, 2012
Sponsor
Abbott
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00711009
Brief Title
Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
Acronym
PROGRESS
Official Title
A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus Infection
Keywords
Human Immunodeficiency Virus infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LPV/r + FTC/TDF
Arm Type
Active Comparator
Arm Description
lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
Arm Title
LPV/r + RAL
Arm Type
Experimental
Arm Description
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir (LPV/r)
Other Intervention Name(s)
ABT-378, lopinavir/ritonavir, LPV/r, Kaletra
Intervention Description
LPV/r 400/100 mg BID
Intervention Type
Drug
Intervention Name(s)
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
Other Intervention Name(s)
emtricitabine/tenofovir disoproxil fumarate, FTC/TDF, Truvada
Intervention Description
FTC/TDF 200/300 mg QD
Intervention Type
Drug
Intervention Name(s)
raltegravir (RAL)
Other Intervention Name(s)
raltegravir, RAL, Isentress, MK-0518
Intervention Description
RAL 400 mg BID
Primary Outcome Measure Information:
Title
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
Description
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.
Time Frame
Baseline to Week 48
Title
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
Description
Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.
Time Frame
Week 96
Title
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
Description
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 Outcome Measure Information:
Title
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
Description
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.
Time Frame
Baseline to Week 96
Title
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
Time Frame
Baseline to Week 96
Title
Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672
Description
Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.
Time Frame
Baseline to Week 96
Title
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.
Description
Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.
Time Frame
Baseline to Week 96
Title
Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
Description
Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.
Time Frame
Baseline to Week 96
Title
Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
Description
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.
Time Frame
Baseline to Week 96
Title
Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
Description
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.
Time Frame
Baseline to Week 96
Title
Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
Description
The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.
Time Frame
Week 96
Title
Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
Description
The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.
Time Frame
Week 96
Title
Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
Description
The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.
Time Frame
Week 96
Title
Mean Change From Baseline in Hemoglobin (Grams/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Hematocrit (Fraction)
Description
Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Platelet Count (x 10^9/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Neutrophils (x 10^9/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Monocytes (x 10^9/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Eosinophils (x 10^9/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Basophils (x 10^9/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Creatinine (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Uric Acid (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Calcium (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Sodium (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Potassium (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Chloride (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Albumin (Grams/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Total Protein (Grams/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Cholesterol (Micromoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Triglycerides (Micromoles/Liter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Lipase (Units/Liter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Magnesium (Millimoles/Liter)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Lactate (Millimoles/Liter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Leptin (Nanograms/Milliliter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Insulin (Picomoles/Liter)
Description
Included in measures of metabolic toxicity
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Urine Specific Gravity
Description
Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Urine pH
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Weight (kg)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Temperature (°F)
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Chest Measurement (cm)
Description
Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Waist Measurement (cm)
Description
Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Mid-Arm Measurement (cm)
Description
Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Hips Measurement (cm)
Description
Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Mid-Thigh Measurement (cm)
Description
Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)
Description
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.
Time Frame
Baseline to Week 96
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)
Description
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
Title
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Podsadecki, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 8431
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Site Reference ID/Investigator# 8432
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Site Reference ID/Investigator# 8394
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Site Reference ID/Investigator# 8393
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Site Reference ID/Investigator# 8425
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Site Reference ID/Investigator# 8402
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Site Reference ID/Investigator# 8396
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Site Reference ID/Investigator# 8395
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Site Reference ID/Investigator# 8429
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Site Reference ID/Investigator# 8424
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Site Reference ID/Investigator# 8426
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Site Reference ID/Investigator# 11461
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Site Reference ID/Investigator# 8403
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Site Reference ID/Investigator# 8433
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Site Reference ID/Investigator# 7963
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Site Reference ID/Investigator# 7831
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Site Reference ID/Investigator# 7959
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1L6
Country
Canada
Facility Name
Site Reference ID/Investigator# 8099
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
Site Reference ID/Investigator# 7695
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Site Reference ID/Investigator# 7960
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Site Reference ID/Investigator# 8063
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Site Reference ID/Investigator# 7821
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Site Reference ID/Investigator# 8052
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Site Reference ID/Investigator# 7789
City
Milan
ZIP/Postal Code
20127
Country
Italy
Facility Name
Site Reference ID/Investigator# 8051
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Site Reference ID/Investigator# 8050
City
Rome
ZIP/Postal Code
00184
Country
Italy
Facility Name
Site Reference ID/Investigator# 8221
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Site Reference ID/Investigator# 7713
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 7700
City
Ponce
ZIP/Postal Code
00717-1563
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 11102
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Site Reference ID/Investigator# 7697
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Site Reference ID/Investigator# 7689
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Site Reference ID/Investigator# 7692
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Site Reference ID/Investigator# 7698
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Site Reference ID/Investigator# 7693
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Site Reference ID/Investigator# 7691
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Site Reference ID/Investigator# 7690
City
Seville
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22730929
Citation
Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R, Tian M, Fredrick L, Podsadecki T, Norton M, Nilius A. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65. doi: 10.1089/aid.2011.0275. Epub 2012 Aug 3.
Results Reference
derived
PubMed Identifier
22180523
Citation
Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naive subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.
Results Reference
derived
Links:
URL
http://dailymed.nlm.nih.gov/dailymed/search.cfm?startswith=Kaletra
Description
Related Info
Learn more about this trial
Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
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