An update showing study results was just posted on

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An update showing study results was just posted on Clinical Trials for this trial (HIV):

Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140 (PRO140)

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Safety data were analyzed for all 40 enrolled subjects. One (1) of 40 subjects experienced an SAE that was deemed not related to the study drug by the Principal Investigator. Twenty-eight (28) of 40 subjects (70%) experienced one or more adverse events (AEs) after receiving at least one dose of PRO140. The most commonly occurring AEs were infections and infestation conditions which were reported by 14 of 40 (35%) subjects. The majority of the reported AEs (63/89; 70.7%) were deemed either unlikely or not related to study treatment by the Investigator. Similarly, the majority of the reported AEs (72/89; 80.8%) were deemed mild in nature.
https://clinicaltrials.gov/ProvidedDocs/78/NC...ot_000.pdf

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The Investigator is also responsible for reporting all SAEs to the appropriate Institutional Review Board (IRB) in accordance with local laws and regulations. The Investigator is responsible for
maintaining documentation in the study file that indicates the IRB has been properly notified. Under 21 CFR 312.32(c), the sponsor is required to notify FDA and all participating investigators in an IND safety report (i.e., 7- or 15-day expedited report) of potentially serious risks from clinical trials or any other source as soon as possible, but no later than 15 calendar days after the sponsor receives the safety information and determines that the information qualifies for reporting.

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