Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307502
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2006-03-27
Brief Title:
Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Cross-sectional Study for the Characterisation of the Pharmacokinetic Parameters of Protease Inhibitors and Non-nucleoside Analog Reverse Transcriptase Inhibitors in the Spanish Population of HIV-infected Subjects
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside analog reverse transcriptase inhibitors NNRTIs and protease inhibitors PIs and the influence of the individual characteristics on the pharmacokinetic parameters in the Spanish population of HIV-infected subjects
Detailed Description:
The antiretrovirals were administered conventionally according to fixed dosage systems or depending on the weight of the individual in the case of certain agents However the plasma levels of antiretrovirals following the administration of a fixed dose present a marked interindividual variability Moreover a significant proportion of the patients on treatment with PIs presented plasma levels regarded as suboptimal in previous studies
Moreover for the correct modification of the dosage of a drug populational data on its pharmacokinetic behaviour during the dosing interval is required Only by integrating this information with the specific characteristics of each individual is it possible using mathematical models to estimate the effect that a modification of the dosage of the drug would have on its plasma concentration However populational data on the pharmacokinetic behaviour of antiretroviral agents are still very limited at this moment and have not always been obtained in populations similar to the one to which they are to be applied
Thus knowing the pharmacokinetic behaviour of the antiretroviral agents in our population and the influence of certain individual characteristics on this behaviour may be of great interest since only in this way will we be able to tailor the dosage of antiretrovirals reliably in our patients
Moreover for the correct modification of the dosage of a drug populational data on its pharmacokinetic behaviour during the dosing interval is required Only by integrating this information with the specific characteristics of each individual is it possible using mathematical models to estimate the effect that a modification of the dosage of the drug would have on its plasma concentration However populational data on the pharmacokinetic behaviour of antiretroviral agents are still very limited at this moment and have not always been obtained in populations similar to the one to which they are to be applied
Thus knowing the pharmacokinetic behaviour of the antiretroviral agents in our population and the influence of certain individual characteristics on this behaviour may be of great interest since only in this way will we be able to tailor the dosage of antiretrovirals reliably in our patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-001516-32 | None | None | None |