NCT00299091

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

March 3, 2006

Last Update Submit

February 13, 2018

Conditions

HIV

Keywords

Therapeutic drug monitoringTreatment NaiveTreatment ExperiencedHIV

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who need to interrupt treatment with efavirenz due to virological failure

    after 96 weeks of follow-up

Secondary Outcomes (5)

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

    after 96 weeks of follow-up

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

    during the 96 weeks of follow-up

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

    during the 96 weeks of follow-up

  • 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

    during the 96 weeks of follow-up

  • To evaluate the variations in CD4 and CD8 lymphocyte count

    during the 96 weeks of follow-up

Study Arms (2)

Control

NO INTERVENTION

Efavirenz capsules 600 mg

Experimental

EXPERIMENTAL

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

Drug: Efavirenz capsules 200 mg and 600 mg

Interventions

Efavirenz capsules 200 mg and 600 mgDRUG

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

Also known as: Sustiva
Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Interventions

efavirenz

Study Officials

  • Bonaventura Clotet, MD, PhD

    Lluita Sida Foundation-HIV Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Bonaventura Clotet

Study Record Dates

First Submitted

March 3, 2006

First Posted

March 6, 2006

Study Start

September 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations

ES(1)