Gilead Sciences ((GILD)) announced an update on their ongoing clinical study.
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Gilead Sciences is conducting a Phase 2/3 open-label study titled ‘A Phase 2/3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1.’ The study aims to assess the pharmacokinetics, safety, and antiviral activity of the combination drug Bictegravir/Lenacapavir (BIC/LEN) in virologically suppressed children and adolescents with HIV-1. This research is significant as it targets a younger demographic that requires tailored HIV treatment options.
The study is testing the combination of two drugs: Lenacapavir and BIC/LEN FDC. These are oral tablets intended to maintain viral suppression in children and adolescents with HIV-1.
The study employs an interventional design with a sequential intervention model and no masking. The primary purpose is treatment, focusing on evaluating the steady-state pharmacokinetics and confirming the dosage of the drugs in children and adolescents.
The study began on July 29, 2024, and the latest update was submitted on August 28, 2025. These dates are crucial as they indicate the study’s progress and the timeline for potential findings that could impact treatment options.
This study update could positively influence Gilead Sciences’ stock performance by showcasing their commitment to expanding HIV treatment options for younger populations. The ongoing research may enhance investor sentiment, especially as the company competes in a market with few pediatric HIV treatment options.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.