The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with Human Immunodeficiency Virus (HIV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
355
raltegravir 400 milligram (mg) by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment
lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
Time frame: 24 Weeks
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
Time frame: 24 Week last patient last visit
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
Time frame: Baseline and Week 12
Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time frame: Baseline and Week 12
Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12
Time frame: Baseline and Week 12
Median Percent Change From Baseline in Serum Triglyceride at Week 12
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time frame: Baseline and Week 12
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24
Time frame: Baseline and Week 24
Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24
Time frame: Baseline and Week 24
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raltegravir 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment
Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24
Time frame: Baseline and Week 24
Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24
Time frame: Baseline and Week 24
Median Percent Change From Baseline in Serum Triglyceride at Week 24
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
Time frame: Baseline and Week 24