Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299091
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2006-03-03
Brief Title:
Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Open Parallel and Randomised Pilot Clinical Trial to Evaluate the Utility of the Therapeutic Monitoring of Plasma Levels of Efavirenz in Hiv-Infected Patients Initiating an Antiretroviral Treatment Regimen With Sustiva
Status:
COMPLETED
Status Verified Date:
2018-02
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:
This is a study on the utility of the modification of doses of efavirenz guided by its plasma concentration therapeutic drug monitoring in HIV-infected patients initiating treatment with Sustiva
Detailed Description:
Currently efavirenz is dosed systematically without taking into account the individual characteristics of each individual patient However plasma concentration of efavirenz may widely vary between different subjects that receive the same dose of the drug interindividual variability
Therapeutic drug monitoring TDM signifies individualised pharmacological dosing based on the plasma levels that each patient presents This strategy has been broadly used in the field of the treatment of other medical conditions and is acquiring growing interest in the field of antiretroviral treatment Thus the use of TDM for the treatment of naïve patients with nelfinavir or with indinavir has translated into an increase in the proportion of individuals with suppressed viral load and also into a reduction in HAART-induced adverse events However data on the utility of the therapeutic monitoring of the levels of efavirenz in HIV-infected patients are very scant
On the basis of the above it might be thought that the modification of the doses of efavirenz guided by its plasma concentration in patients receiving this drug and whose plasma levels of efavirenz are outside the therapeutic range might improve the tolerability of the treatment without compromising virological efficacy
Therapeutic drug monitoring TDM signifies individualised pharmacological dosing based on the plasma levels that each patient presents This strategy has been broadly used in the field of the treatment of other medical conditions and is acquiring growing interest in the field of antiretroviral treatment Thus the use of TDM for the treatment of naïve patients with nelfinavir or with indinavir has translated into an increase in the proportion of individuals with suppressed viral load and also into a reduction in HAART-induced adverse events However data on the utility of the therapeutic monitoring of the levels of efavirenz in HIV-infected patients are very scant
On the basis of the above it might be thought that the modification of the doses of efavirenz guided by its plasma concentration in patients receiving this drug and whose plasma levels of efavirenz are outside the therapeutic range might improve the tolerability of the treatment without compromising virological efficacy
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 |
|---|---|---|---|
| 2005-002493-30 | None | None | None |