Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location Site Reference ID/Investigator# 8431, Phoenix, Arizona, 85006 | Status Not Available | |
Location Site Reference ID/Investigator# 8432, Beverly Hills, California, 90211 | Status Not Available | |
Location Site Reference ID/Investigator# 8394, Atlantis, Florida, 33462 | Status Not Available | |
Location Site Reference ID/Investigator# 8393, Fort Pierce, Florida, 34982 | Status Not Available | |
Location Site Reference ID/Investigator# 8425, Orlando, Florida, 32803 | Status Not Available | |
Location Site Reference ID/Investigator# 8402, Tampa, Florida, 33614 | Status Not Available | |
Location Site Reference ID/Investigator# 8396, Vero Beach, Florida, 32960 | Status Not Available | |
Location Site Reference ID/Investigator# 8395, Atlanta, Georgia, 30303 | Status Not Available | |
Location Site Reference ID/Investigator# 8429, Decatur, Georgia, 30033 | Status Not Available | |
Location Site Reference ID/Investigator# 8424, Boston, Massachusetts, 02215 | Status Not Available | |
Location Site Reference ID/Investigator# 8426, Charlotte, North Carolina, 28209 | Status Not Available | |
Location Site Reference ID/Investigator# 11461, Huntersville, North Carolina, 28078 | Status Not Available | |
Location Site Reference ID/Investigator# 8403, Dallas, Texas, 75246 | Status Not Available | |
Location Site Reference ID/Investigator# 8433, Houston, Texas, 77004 | Status Not Available | |
Location Site Reference ID/Investigator# 7963, Ottawa, Ontario, K1H 8L6 | Status Not Available | |
Location Site Reference ID/Investigator# 7831, Toronto, Ontario, M4N 3M5 | Status Not Available | |
Location Site Reference ID/Investigator# 7959, Toronto, Ontario, M5B 1L6 | Status Not Available | |
Location Site Reference ID/Investigator# 8099, Montreal, Quebec, H2L 5B1 | Status Not Available | |
Location Site Reference ID/Investigator# 7713, Bayamon, 00959 | Status Not Available | |
Location Site Reference ID/Investigator# 7700, Ponce, 00717-1563 | Status Not Available |
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.
Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
Time Frame: Baseline to Week 48
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
Time Frame: Week 96
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
Time Frame: 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
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 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.
Time Frame: Baseline to Week 96
Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
Time Frame: Baseline to Week 96
Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
Time Frame: Baseline to Week 96
Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
Time Frame: Baseline to Week 96
Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame: Week 96
Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
Time Frame: Week 96
Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
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)
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)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
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)
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)
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)
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)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Lactate (Millimoles/Liter)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Leptin (Nanograms/Milliliter)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Insulin (Picomoles/Liter)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Urine Specific Gravity
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)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Waist Measurement (cm)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Mid-Arm Measurement (cm)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Hips Measurement (cm)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Mid-Thigh Measurement (cm)
Time Frame: Baseline to Week 96
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)
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)
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)
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)
Time Frame: Baseline to Week 96
Interventions:
- Drug: lopinavir/ritonavir (LPV/r)
- Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
- Drug: raltegravir (RAL)
Enrollment:
206
Available Documents
FaFilePdfScientific Result Summary (English)Additional Information
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