I agree with Jake2212, Amarex is a sideshow and at this juncture it makes sense to let it play out, not focus on it…we are still 6 months out from the arbitrator final hearing and I don’t wish to rekindle the back and forth on that one. Not to dismiss the potential impact to Cytodyn on the outcome of the Amarex dispute, but in the center ring under the Big Top right now is the HiV immune modulation trial of which I sense we will receive clinical trial protocol approval news soon from the FDA.
Here is a good summary of the clinical challenge and a survey of serological makers that might stand in as potential end-points for evaluation.
https://www.mdpi.com/2227-9059/11/1/159#
I won’t conjecture on the trial endpoints, the best minds at Cytodyn in collaboration with the FDA have figured that out and hopefully we can look at the details of the study protocol on clinicaltrials.gov soon. Based on the following don’t be shocked if the CD4/CD8 ratio makes the short list. They will undoubtedly need to control for important variables also such as statin use which can impact the inflammatory state. There is a reason why Bruce Patterson is using statins in conjunction with Maraviroc for their approved protocol study for longhaulers, which at the core I believe is about immune dysregulation.
Not up for dispute is the importance of this study from a clinical standpoint. Like “The Shot Heard Around The World”, the reverberations will be felt well beyond the HIV population.
“Only the CD4/CD8 ratio and number of CD8+ T cells are currently indicated in the EACS guidelines [139] as markers to be evaluated at baseline and during follow-up of patients under ART, as numerous studies on large case series have demonstrated their role as predictive markers of immune reconstitution and normalization of immune functions. In fact, in addition to the absolute number and percentage of CD4+ T cells, they represent strong predictors of the risk of non-AIDS events and mortality in HIV-1 patients undergoing antiretroviral therapy.“
Here is a good summary of the clinical challenge and a survey of serological makers that might stand in as potential end-points for evaluation.
https://www.mdpi.com/2227-9059/11/1/159#
I won’t conjecture on the trial endpoints, the best minds at Cytodyn in collaboration with the FDA have figured that out and hopefully we can look at the details of the study protocol on clinicaltrials.gov soon. Based on the following don’t be shocked if the CD4/CD8 ratio makes the short list. They will undoubtedly need to control for important variables also such as statin use which can impact the inflammatory state. There is a reason why Bruce Patterson is using statins in conjunction with Maraviroc for their approved protocol study for longhaulers, which at the core I believe is about immune dysregulation.
Not up for dispute is the importance of this study from a clinical standpoint. Like “The Shot Heard Around The World”, the reverberations will be felt well beyond the HIV population.
“Only the CD4/CD8 ratio and number of CD8+ T cells are currently indicated in the EACS guidelines [139] as markers to be evaluated at baseline and during follow-up of patients under ART, as numerous studies on large case series have demonstrated their role as predictive markers of immune reconstitution and normalization of immune functions. In fact, in addition to the absolute number and percentage of CD4+ T cells, they represent strong predictors of the risk of non-AIDS events and mortality in HIV-1 patients undergoing antiretroviral therapy.“
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