GlaxoSmithKline ((GSK)), GlaxoSmithKline plc (UK) ((GB:GSK)) announced an update on their ongoing clinical study.
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GlaxoSmithKline (GSK), in collaboration with ViiV Healthcare and PPD Development, is conducting a Phase IIIb study titled ‘A Phase IIIb, Multi-center, Non-randomized, Parallel-group, Open-label, Hybrid Type I Study Evaluating the Efficacy, Safety, Implementation Effectiveness, and Patient-reported Outcomes of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Followed by Participant-determined Optional Switch to Long-acting Intramuscular Cabotegravir Plus Rilpivirine Every Two Months for the Maintenance of Virologic Suppression in Antiretroviral Therapy Naive Adults Living With HIV-1.’ The study aims to assess the effectiveness and safety of two antiretroviral regimens in HIV-1 patients who have not previously received treatment, providing insights into patient preferences and outcomes.
The study is testing two interventions: an oral tablet of dolutegravir/lamivudine (DTG/3TC) taken once daily, and a long-acting injectable regimen of cabotegravir plus rilpivirine (CAB + RPV LA) administered every two months. These treatments aim to maintain virologic suppression in HIV-1 patients.
This interventional study is non-randomized with a parallel-group design, focusing on treatment as its primary purpose. It is open-label, meaning both researchers and participants know which treatment is being administered.
The study began on July 28, 2023, with an estimated completion date of July 16, 2025. These dates are crucial as they indicate the timeline for data collection and potential market impact.
The study’s progress could influence GSK’s stock performance by demonstrating advancements in HIV treatment options, potentially enhancing investor confidence. The competitive landscape in HIV treatment is significant, with several companies vying for market share, making this study’s outcomes particularly relevant.
The study is ongoing, with further details available on the ClinicalTrials portal.