This study randomized 3 arm multicenter open label trial in sqvhc experienced subjects. Subjects were randomized to receive either (arm 1) a continuation of the hard capsule saquinavir (sqvhc) or (arm 2) the new soft gelatin capsule of saquinavir (sqvsgc) which replaced the sqvhc in their drug regimen or (arm 3) indinavir (idv) which replaced the sqvhc in their drug regimen. Subjects continued on their same non-protease anti- HIV drugs, if on any therapy, for at least the first 8 weeks. An interim analysis was performed after 72 subjects had completed 8 weeks of the trial. This interim analysis was not in the original protocol design but was incorporated into version 2.0 Of the protocol because accrual was slower than anticipated. The primary objective of the interim analysis was to examine the 8 week changes in HIV-RNA in the IDV and sqvsgc arms and ensure that they were large enough for the study to continue. The guidelines developed by the study team suggested that if either arm did not show acute HIV-RNA reduction of at least 0.7 Log 10 compared to sqvhc, the arm was to be considered for termination.
NIH ExPorter
NIH ExPorter