Study of Lopinavir/Ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, When Coadministered With Nucleoside Reverse Transcriptase Inhibitors in Antiretroviral Naive Human Immunodeficiency Virus Type 1 Infected Subjects
Human Immunodeficiency Virus Infections
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus Infections focused on measuring Human Immunodeficiency Virus Infections
Eligibility Criteria
Inclusion Criteria Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral naïve adults at least 18 years of age with < 7 days of prior antiretroviral therapy. Subjects had plasma HIV-1 ribonucleic acid (RNA) levels >= 1,000 copies/mL at screening and were not acutely ill. Female subjects were nonpregnant and nonlactating. Exclusion Criteria Subjects were excluded if screening laboratory analyses showed any of the following abnormal laboratory results: Presence of hepatitis B surface antigen (HBsAg) Hemoglobin <= 8.0 g/dL Absolute neutrophil count <= 750 cells/microliter Platelet count <= 50,000 per mL Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3.0 x Upper Limit of Normal (ULN) Calculated creatinine clearance < 50 mL/min
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
LPV/r 800/200 mg QD Tablet
LPV/r 800/200 mg QD SGC (Through Week 8)
LPV/r 400/100 mg BID Tablet
LPV/r 400/100 mg BID SGC (Through Week 8)