Unexpected Finding of Delayed-Onset Seizures in HIV-Positive, Treatment-Experienced Subjects in the Phase Iib Evaluation of Fosdevirine (Gsk2248761)

  title={Unexpected Finding of Delayed-Onset Seizures in HIV-Positive, Treatment-Experienced Subjects in the Phase Iib Evaluation of Fosdevirine (Gsk2248761)},
  author={David A. Margolis and Joseph J. Eron and Edwin Dejesus and Scott White and Paul G Wannamaker and Britt S Stancil and Mark Johnson},
  journal={Antiviral Therapy},
  pages={69 - 78}
Background Fosdevirine (GSK2248761) is a non-nucleoside reverse transcriptase inhibitor with HIV-1 activity against common efavirenz-resistant strains. Two partially blind, randomized, Phase IIb studies were initiated (1 in treatment-naive and 1 in treatment-experienced subjects with HIV) to select a once-daily dose of fosdevirine for Phase III trials. Methods In the SIGNET study, treatment-naive subjects were randomized 1:1:1 to receive once-daily fosdevirine 100 or 200 mg or efavirenz 600 mg… 

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