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Thigh Injections of Cabotegravir + Rilpivirine in Virally Suppressed Adults With Human Immunodeficiency Virus Type 1: A Substudy of the Phase 3b ATLAS-2M Study.
Clin Infect Dis
January 2025
ViiV Healthcare, Durham, North Carolina, USA.
Background: Cabotegravir + rilpivirine (CAB + RPV) administered via intramuscular gluteal injections is the first complete long-acting regimen for maintaining human immunodeficiency virus type 1 (HIV-1) virologic suppression. We present substudy results on short-term repeat intramuscular CAB + RPV long-acting thigh injections in participants with ≥3 years of experience with gluteal administration during the ATLAS-2M study.
Methods: Substudy phases included screening, thigh injection (day 1-week 16), and return to gluteal injection (week 16-week 24).
Unlabelled: Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate that the protocol contents in past EPDF trials frequently lacked completeness and clarity.
View Article and Find Full Text PDFUnlabelled: Early phase dose-finding (EPDF) trials are key in the development of novel therapies, with their findings directly informing subsequent clinical development phases and providing valuable insights for reverse translation. Comprehensive and transparent reporting of these studies is critical for their accurate and critical interpretation, which may improve and expedite therapeutic development. However, quality of reporting of design characteristics and results from EPDF trials is often variable and incomplete.
View Article and Find Full Text PDFThe European Commission mandated EFSA to assess the toxicity of bromide, the existing maximum residue levels (MRLs), and possible transfer from feed into food of animal origin. The critical effects of bromide in experimental animals are on the thyroid and central nervous system. Changes in thyroid hormone homeostasis could result in neurodevelopmental toxicity, among other adverse effects.
View Article and Find Full Text PDFSafety of Cefazolin Perioperative Prophylaxis in Plastic Surgery Patients With Penicillin Allergy: A Retrospective Chart Review.
Plast Surg (Oakv)
February 2025
Division of Allergy and Immunology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Antimicrobial prophylaxis is crucial in reducing surgical site infections (SSIs). First-generation cephalosporins are commonly first line, but issues arise when patients report a penicillin allergy. Although up to 10% of Americans report a penicillin allergy, up to 95% are not truly allergic.
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