The purpose of this study was to compare the safety and tolerability of the to-be-marketed lopinavir/ritonavir (LPV/r) tablet formulation with the marketed soft gel capsule (SGC) formulation and to compare the safety, tolerability, and antiviral activity of once daily (QD) and twice daily (BID) dosing of the LPV/r tablet formulation in combination with select nucleoside reverse transcriptase inhibitors (NRTIs) in patients who have not previously received antiretroviral treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
664
LPV/r 800/200 mg once daily (QD) tablet + emtricitabine (FTC) 200 mg QD + tenofovir disoproxil fumarate (TDF) 300 mg QD
LPV/r 800/200 mg QD soft gel capsule (SGC) + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 800/200 mg QD Tablet + FTC 200 mg QD + TDF 300 mg QD
LPV/r 400/100 mg twice daily (BID) tablet + FTC 200 mg QD + TDF 300 mg QD
LPV/r 400/100 mg BID SGC + FTC 200 mg QD + TDF 300 mg QD (8 weeks) followed by LPV/r 400/100 mg BID Tablet + FTC 200 mg QD + TDF 300 mg QD
Site Reference ID/Investigator# 823
Phoenix, Arizona, United States
Site Reference ID/Investigator# 846
Phoenix, Arizona, United States
Site Reference ID/Investigator# 851
Beverly Hills, California, United States
Site Reference ID/Investigator# 872
Fountain Valley, California, United States
Site Reference ID/Investigator# 826
Long Beach, California, United States
Percentage of Subjects With Adverse Events of Diarrhea During the First 8 Weeks
Time frame: Week 8
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 48
Time frame: Week 48
Percentage of Subjects With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/mL at Week 96
Time frame: Week 96 (End of Study)
Mean Change From Baseline to Week 96 in CD4+ T Cell Counts
Time frame: Week 96 (End of Study)
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Site Reference ID/Investigator# 876
Newport Beach, California, United States
Site Reference ID/Investigator# 875
Washington D.C., District of Columbia, United States
Site Reference ID/Investigator# 870
Atlantis, Florida, United States
Site Reference ID/Investigator# 844
Fort Lauderdale, Florida, United States
Site Reference ID/Investigator# 874
Miami, Florida, United States
...and 119 more locations