RE:RE:RE:RE:RE:Can someone explain
This is the only primary endpoints comparing two drugs:
https://classic.clinicaltrials.gov/ct2/show/NCT03913195
- Pharmacokinetics(1) of Trogarzo infusion versus intramuscular injection in the Intramuscular Injection Group [ Time Frame: Day 1 infusion versus Day 71 intramusuclar injection ]Ratio of Area Under the Curve of Serum levels of Trogarzo given by 15 minute infusion versus Area Under the Curve of Serum levels of Trogarzo given by intramuscular injection
- Pharmacokinetics(2) of Trogarzo infusion versus intramuscular injection in the Intramuscular Injection Group [ Time Frame: Day 1 infusion versus Day 71 intramusuclar injection ]Ratio of Trough Serum levels of Trogarzo given by 15 minute infusion versus Trough Serum levels of Trogarzo given by intramuscular injection
As for AUC:
"In the field of pharmacokinetics, the area under the curve (AUC) is the definite integral of the concentration of a drug in blood plasma as a function of time (this can be done using liquid chromatography–mass spectrometry[1]). In practice, the drug concentration is measured at certain discrete points in time and the trapezoidal rule is used to estimate AUC. In pharmacology, the area under the plot of plasma concentration of a drug versus time after dosage (called “area under the curve” or AUC) gives insight into the extent of exposure to a drug and its clearance rate from the body.[2]."
They are talking about comparing IV versus IM using statistical analysis. They also said the mean through serum levels were comparable no mentioning of AUC/ serum
concentration versus "the time of dosage".
So again plasma concentration in a period of time which equals exposure is what I believe wasn't met comparing the two administration methods. As I understand and mentioned earlier concentration over a period of time seems to be issue so the reduction of viral loads(secondary endpoint) has nothing to do with primary endpoint which is included in the trial as this is a small trial that's why I believe the validation of efficacy of IM administration is based on the comparison of IM/IV administrations' pharmacokinetics as IV administration is already approved.
In my previous posts I wrote "the reduction of viral load didn't meet the endpoint" which can come across confusing and maybe that's why it can be interpreted as "false" as I should not mix the results from primary and secondary endpoints! My question is can they use the secondary endpoint results and still submit these results for this small trial without the comparison of the pharmacokinetics of IV and IM?
And yes this is my interpretation only, feel free to add yours or correct mine.