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

Information source: Germans Trias i Pujol Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV

Intervention: Efavirenz capsules 600 mg (Drug); Efavirenz capsules 200 mg and 600 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Germans Trias i Pujol Hospital

Official(s) and/or principal investigator(s):
Bonaventura Clotet, MD, PhD, Principal Investigator, Affiliation: Lluita Sida Foundation-HIV Unit

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The proportion of patients who need to interrupt treatment with efavirenz due to virological failure

Secondary outcome:

The proportion of patients who need to interrupt treatment with efavirenz due to adverse side effects

To determine the incidence of adverse events and the toxicity profile (haemogram, AST/ALT/FA/GGT, creatinine, urea)

To evaluate the proportion of patients with plasma levels of efavirenz between 1.0 and 4.0 mg/L

To evaluate the relationship between the appearance of secondary events during treatment with efavirenz and the patients' demographic and clinical characteristics, as well the plasma concentration of efavirenz

To evaluate the variations in CD4 and CD8 lymphocyte count

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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Germans Trias i Pujol Hospital, Badalona, Barcelona 08916, Spain
Additional Information

Starting date: September 2006
Last updated: October 14, 2008

Page last updated: August 23, 2015

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