A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment Naive HIV-Infected Subjects

简要总结

主要结局

次要结局

• Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48(At Week 48 from Baseline)
• Number of Nonresponders at Week 8(At Week 8 from Baseline)
• Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96(At Weeks 48 and 96 from Baseline)
• Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24(At Week 24 from Baseline)
• Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96(At Week 96 from Baseline)
• Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count(From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24)
• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation(Week 1 to Week 96, continuously)
• Baseline and Mean Change From Baseline in Total Cholesterol Levels(From Baseline to Week 24 and Week 48)
• Mean Change From Baseline in Total Bilirubin Level(From Baseline to Week 24 and Week 48)
• Mean Change From Baseline in Electrocardiogram Findings(From Baseline to Week 24)
• Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval(At Week 2 from Baseline)
• Raltegravir Cmax in 1 Dosing Interval(At Week 2 from Baseline)
• Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)(At Week 2 from Baseline)
• Raltegravir Tmax(At Week 2 from Baseline)
• Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose(At Week 2 from Baseline)
• Raltegravir Cmin 12 Hours Postdose(At Week 2 from Baseline)
• Atazanavir Cmin Prior to the Morning Dose(At Week 2 from Baseline)
• Raltegravir Cmin Prior to the Morning Dose(At Week 2 from Baseline)
• Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval(At Week 2 from Baseline)
• Raltegravir AUC (0-12h) in 1 Dosing Interval(At Week 2 from Baseline)
• Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval(At Week 2 from Baseline)
• Atazanavir Individual Inhibitory Quotient (IQ)(At Week 2 from Baseline)
• Atazanavir Terminal Elimination Half Life(At Week 2 from Baseline)
• Raltegravir Terminal Elimination Half Life(At Week 2 from Baseline)
• Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants(While on treatment from Baseline through Week 96)
• Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4(While on treatment from Baseline through Week 96)
• Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)(While on treatment from Baseline through Week 96)
• Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4(While on treatment from Baseline through Week 96)