GSK revises HIV drug study criteria after patient group input
GSK plc announced it will amend the inclusion criteria for an ongoing study of an investigational integrase inhibitor, S/GSK1349572. The changes follow input from patient advocacy groups, prioritizing those most in need of treatment.
GSK plc has announced plans to revise the inclusion criteria for Study ING112276, a dose-ranging study of the investigational integrase inhibitor S/GSK1349572. The amendments were made in collaboration with the European AIDS Treatment Group (EATG) and the Drug Development Committee (DDC) of the AIDS Treatment Activists Coalition (ATAC).
The revised criteria increase the minimum allowable CD4+ cell count to 200 cells/mm³, or higher as local guidelines dictate. This change aims to ensure that patients with lower CD4+ counts, who have a greater immediate need for therapy, are treated with established standard of care agents first. The decision reflects evolving regulatory recommendations and consensus within the HIV community.
Dr. Garrett Nichols, Co-Project Leader for clinical development of S/GSK1349572 at Shionogi-GlaxoSmithKline Pharmaceuticals, stated that the change is not based on new safety concerns. Instead, it reflects a commitment to focus on the needs of the broader HIV community. Both EATG and DDC have expressed satisfaction with GSK's willingness to incorporate their perspectives.
Integrase inhibitors are a class of anti-HIV drugs that block viral replication by preventing the integration of viral DNA into host immune cells. The development of new drugs like S/GSK1349572 is important for addressing drug resistance and expanding treatment options for individuals living with HIV.