A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD neVirapine Extended Release Formulation in Comparison to 200 mg BID neVirapinE Immediate Release in Combination With Truvada® in Antiretroviral Therapy naïve HIV-1 Infected Patients (VERxVE)

简要总结

主要结局

次要结局

• Kaplan-Meier Estimates for Time to New AIDS or AIDS-related Progression Event or Death, Full Analysis Set Population(week 0 to 144)
• Occurrence of Rashes(until last patient completed 144 weeks (up to 193 weeks))
• Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population(week 0 to 144)
• Proportion of Sustained Virologic Response at Week 144 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population(week 144)
• Comparison of HIV-1 Viral Load (log10 Copies/mL) Change From Baseline at Week 144, Full Analysis Set Population(baseline, week 144)
• Comparison of CD4+ Cell Count (Cells/Cubic Millimeter) Change From Baseline at Week 144, Full Analysis Set Population(baseline, week 144)
• Occurrence of Elevations in Laboratory Measurement by DAIDS Grade(until last patient completed 144 weeks (up to 193 weeks))
• Kaplan -Meier Estimate of Cumulative Probability of Permanent Discontinuation of Study Medication(week 0 to 144)
• Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 ALT/AST Abnormalities(week 0 to 72)
• Kaplan -Meier Estimate of Cumulative Probability of Grade 3 or 4 Asymptotic Transaminases Abnormalities(week 0 to 72)
• Kaplan -Meier Estimate of Cumulative Probability of Clinical Hepatic Events(week 0 to 72)
• Kaplan -Meier Estimate of Cumulative Probability of Group III or IV Drug-related Rash(week 0 to 72)
• Relative Bioavailability Trough C_pre,ss,1(week 132)
• Occurrence of Hepatic Events(until last patient completed 144 weeks (up to 193 weeks))