Outcomes
virologic failure, AIDS, virologic suppression, intolerance or adverse event
ADVERSE EVENT, ADVERSE EVENTS, ADVERSE EVENT, AIDS, SECONDARY
The primary outcome was proportion with virologic suppression (defined as HIV-1 RNA <50 copies/mL) at week 24. We conducted a modified intention-to-treat (mITT) analysis according to the US Food and Drug Administration (FDA) snapshot approach, which defines failure as any 1 of HIV-1 RNA measurements ≥50 copies/mL, missing HIV-1 RNA within the window, intolerance or adverse event because of any study drug requiring switch, or loss to follow-up [The secondary outcomes included virologic suppression at week 12 (with the same definition as for the primary outcome), proportion with HIV-1 RNA <400 copies/mL at weeks 12 and 24 (mITT; FDA Snapshot), time to virologic suppression, emergence of resistance mutations in participants meeting protocol-defined criteria for GART, including those with virologic failure (defined as 2 consecutive HIV-1 RNA ≥1000 copies/mL after week 12), and proportion developing grade 3 or 4 adverse events and serious adverse events. Adverse events were evaluated and graded at all study visits according to the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events [