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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Efavirenz capsules 600 mg

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

Modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring)

Group Type EXPERIMENTAL

Efavirenz capsules 200 mg and 600 mg

Intervention Type DRUG

Modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring)

Interventions

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Efavirenz capsules 200 mg and 600 mg

Modification of doses of efavirenz guided by its plasma concentration (therapeutic drug monitoring)

Intervention Type DRUG

Other Intervention Names

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Sustiva

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No