Status:
COMPLETED
Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients
Lead Sponsor:
Germans Trias i Pujol Hospital
Conditions:
HIV
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- HIV-1 patients.
- According to the criteria of the treating physician, the need to initiate a regimen of antiretroviral treatment that includes efavirenz (both antiretroviral-naive patients and others on treatment with protease inhibitors switching to efavirenz for salvage reasons or for simplification of the anti-retroviral therapy are included).
- Absence of opportunistic infections and/or tumours in the three months prior to inclusion.
Exclusion
- History of allergic hypersensitivity to the investigational drug.
- History of previous failure with antiretroviral treatment with non-nucleoside reverse transcriptase inhibitors or previously documented resistance to efavirenz
- History of psychiatric comorbidity which, in the investigator's opinion, renders the use of efavirenz inadvisable.
- Active consumption of alcohol (\>50 g/day) or other illegal drugs (except cannabis)
- Suspicion of unsuitable compliance with the antiretroviral treatment.
- Pregnant women or breast-feeding mothers.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00299091
Start Date
September 1 2006
End Date
October 1 2008
Last Update
February 14 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916