Viiv have recently announced the phase III program for their new...

Viiv have recently announced the phase III program for their new integrase for frontline use

much less pts that the earlier naive statement on the board of 'significantly more than 1800 pts'...

both non-inferior studies, and interesting design in their treatment experienced study, with OBR having 1-2 active agents...


SPRING-2 Study Design (ING113086)

SPRING-2 is a Phase III, randomized, blinded, active-controlled, multicenter, parallel group, non-inferiority study. The study will include approximately 788 HIV-1 infected treatment-na?ve patients. The non-inferiority study will compare efficacy and safety outcomes of ?572 and raltegravir (RAL); both treatment arms will be administered with investigator-selected dual nucleoside reverse transcriptase inhibitor therapy (either ABC/3TC or TDF/FTC).

The primary objective for SPRING-2 will be to demonstrate the antiviral activity of ?572 50mg administered once-daily compared to RAL 400mg administered twice daily over 48-weeks. Secondary objectives include the assessment of antiviral activity of ?572 compared to RAL at 96-weeks, to compare the tolerability, long-term safety and antiviral and immunologic activity of ?572 to RAL, and to evaluate viral resistance in subjects experiencing virological failure.

SAILING Study Design (ING111762)

SAILING is a Phase III, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will include approximately 688 HIV-1 infected treatment-experienced, integrase-na?ve subjects. The non-inferiority study will assess the antiviral efficacy of ?572 compared to RAL.

The primary objective for SAILING will be to demonstrate the antiviral efficacy of ?572 50mg once-daily compared to RAL 400mg twice-daily both in combination with a background regimen consisting of one to two fully active agents at 48-weeks. Secondary objectives will evaluate the long-term antiviral activity, pharmacokinetics (PK), the relationship between PK and antiviral activity, tolerability and safety of ?572 versus RAL.