Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr . BONAVENTURA CLOTET; Germans Trias i Pujol Hospital
• Treatments: Efavirenz

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.