Table 2

CAPRISA 012B group, dose and arm allocation

GroupParticipantsRegimenSA site (N=66)Dose (mg/kg)
Group 1: dose escalation of IV administration of CAP256V2LS
 1aHIV negativeCAP256V2LS45 mg/kg IV one dose
 1bHIV negativeCAP256V2LS410 mg/kg IV one dose
 1cHIV positiveCAP256V2LS4/2§20 mg/kg IV one dose
 1dHIV positiveCAP256V2LS4/4§20 mg/kg IV one dose
Group 2: dose escalation of SC administration of CAP256V2LS
 2aHIV negativeCAP256V2LS45 mg/kg SC one dose
 2bHIV negativeCAP256V2LS*45 mg/kg SC one dose
 2cHIV negativeCAP256V2LS*410 mg/kg SC one dose
 2dHIV negativeCAP256V2LS*410 mg/kg SC with one repeat dose at 16/24 weeks†
 2eHIV negativeCAP256V2LS*420 mg/kg SC one dose
 2fHIV negativeCAP256V2LS*420 mg/kg SC with one repeat dose at 16/24 weeks†
Group 3: dose escalation of the two antibody combinations
 3aHIV negativeCAP256V2LS*+VRC07-523.LS*4/1§10 mg/kg SC/10 mg/kg SC one dose
 3bHIV negativeCAP256V2LS*+VRC07-523.LS*4/1§20 mg/kg SC/20 mg/kg SC one dose
 3cHIV negativeCAP256V2LS*+PGT121‡4/1§20 mg/kg SC/5 mg/kg SC one dose
Group 4: three antibody combination
 4aHIV negativeCAP256V2LS*+PGT121‡+
VRC07-523.LS*		4/1§20 mg/kg SC/5 mg/kg SC/20 mg/kg SC one dose

  • *Antibody will be injected with hyaluronidase, so that the antibody dose can be administered as a single SC injection.

  • †First two participants will receive two doses 24 weeks apart and the next two participants will receive two doses 16 weeks apart.

  • ‡PGT121 may be replaced with PGT121LS at a higher dose, based on its availability at the time of study initiation.

  • §Placebo allocation.

  • SC, subcutaneous.