USFDA places clinical hold on Gilead Sciences trials testing HIV pill combination
Foster City: Gilead Sciences has announced that the U.S. Food and Drug Administration has placed a clinical hold on its HIV treatment trials of GS-1720 (an investigational integrase strand transfer inhibitor) and/or GS-4182 (an investigational capsid inhibitor).
The clinical hold is due to the identification of a safety signal of decreases in CD4+T-cell (CD4) and absolute lymphocyte counts in a subset of participants receiving the combination of GS-1720 and GS-4182.
Clinical trial investigators involved in the trials have been informed of these actions. GS-1720 and GS-4182 are investigational agents and have not been approved anywhere globally.
"We intend to investigate and pursue the potential of both agents and are committed to working with regulatory authorities to resolve the issues underlying the clinical hold," Gilead stated.
Gilead has multiple other long-acting oral and injectable investigational HIV treatment combinations under evaluation in clinical and preclinical studies, including combinations with weekly, monthly, quarterly, and twice-yearly dosing. This hold does not impact these combinations or their respective clinical or pre-clinical development programs.
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