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Randomized Clinical Trial to Assess the Efficacy and Safety of Concomitant Use of Rifampicin and Efavirenz 600 X 800mg

NCT00533390 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2015-11-10

No results posted yet for this study

Summary

Rifampicin is a potent inducer of the CYP450 and decrease the plasmatic concentration of NNRTI and Protease Inhibitors. In our study we are going to compare the 600 an 800mg doses of efavirenz concomitant of rifampicin use to treat tuberculosis. The hypothesis is that the 800 mg dose would be more adequate than the 600mg

Conditions

Interventions

DRUG

efavirenz

600mg X 800mg QID during TB therapy with rifampicin associated with other antituberculosis drugs in patients concomitant treated for tuberculosis and AIDS

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • Valeria C Rolla, MD DSc · Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

  • Maria Cristina S Lourenço, MSc · Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

  • Flávia M Sant'Anna, MSc · Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

  • Mariza G Morgado, DSc · Instituto Oswaldo Cruz, Fiocruz

  • Pedro E Americano do Brasil, MD MSc · Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

  • Carolina S Smaltz, PhD student · Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz

  • Jose L Teixeira, Pharmacist · Instituto de pesquisa Clinica Evandro Chagas

  • David J Hadad, PhD · Federal University of Espirito Santo

  • Reynaldo Dietze, PhD · Federal University of Espirito Santo

  • Moises Palaci, PhD · Federal University of Espirito Santo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00533390 on ClinicalTrials.gov