Randomized Clinical Trial to Assess the Efficacy and Safety of Concomitant Use of Rifampicin and Efavirenz 600 X 800mg (IPEC-EFV)

This study has been terminated.
(Lack of financial support and low inclusion rate)
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
UNODOC
Information provided by (Responsible Party):
Valeria Cavalcanti Rolla, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00533390
First received: September 19, 2007
Last updated: December 28, 2012
Last verified: December 2012

September 19, 2007
December 28, 2012
January 2007
October 2012   (final data collection date for primary outcome measure)
proportion of patients with viral load < 80 at the end of tuberculosis therapy proportion of adverse events in each group [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
proportion of patients with viral load < 80 at the end of tuberculosis therapy proportion of adverse events in each group [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00533390 on ClinicalTrials.gov Archive Site
Immunologic reconstitution Genotyping resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Immunologic reconstitution Genotyping resistance [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Randomized Clinical Trial to Assess the Efficacy and Safety of Concomitant Use of Rifampicin and Efavirenz 600 X 800mg
Anti-retroviral Efficacy, Tolerance and Other Pharmacologic Interactions of the Non Nucleoside Analog Efavirenz in Association With Rifampicin to Treat Tuberculosis and AIDS

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

The study consist in a open label randomized clinical trial comparing efavirenz 600mg QID versus efavirenz 800mg QID in patients with tuberculosis (treated with regimens including rifampicin) and AIDS diagnosis. The total duration of the study is 6 months for each patient. All eligible patient will be treated with a fist line regimen for tuberculosis according to Brazilian guidelines: rifampicin (600mg QID); isoniazid (400mg QID) e pyrazinamide (2g QID) during 6 months for a weight of 45 kg or more and adapted doses for persons with less than 45 kg. For patients with previous history of TB therapy etambutol 1.200mg QID will be added to the regimen.

Both groups will receive nucleoside reverse transcriptase inhibitors (NRTI)and a non nucleoside transcriptase inhibitor (NNRTI) to treat HIV. The ITRN of first choice will be zidovudine and lamivudine association. Patients presenting contra indication for the use of those drugs will receive others NRTI. The NNRTI is efavirenz (800 or 600mg).

Antiretrovirals will be initiated 30 days after stable TB therapy. In case of adverse events during TB therapy that lead to treatment interruption, the study drugs will be delayed until the 30th day after triple therapy for TB. During HIV therapy NRTI can be changed in case of intolerance

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tuberculosis
  • HIV Infections
Drug: efavirenz
600mg X 800mg QID during TB therapy with rifampicin associated with other antituberculosis drugs in patients concomitant treated for tuberculosis and AIDS
Other Names:
  • Stocrin
  • Sustiva
  • Experimental: 2
    Efavirenz 800 mg (tablet) QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin
    Intervention: Drug: efavirenz
  • Active Comparator: 1
    Efavirenz 600 mg (tablet) QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin
    Intervention: Drug: efavirenz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
130
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults with tuberculosis diagnosis, HIV positive.
  • Agreement to avoid not allowed drugs during the trial, agreement to participate in the study (informed consent)

Exclusion Criteria:

  • Active liver disease
  • Pregnancy or breast feeding
  • CD4 counts >350
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00533390
CAAE-0017.1.009.000-03
No
Valeria Cavalcanti Rolla, Oswaldo Cruz Foundation
Oswaldo Cruz Foundation
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • UNODOC
Principal Investigator: Valeria C Rolla, MD DSc Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz
Study Chair: Maria Cristina S Lourenço, MSc Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz
Study Chair: Flávia M Sant'Anna, MSc Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz
Study Chair: Mariza G Morgado, DSc Instituto Oswaldo Cruz, Fiocruz
Study Chair: Pedro E Americano do Brasil, MD MSc Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz
Study Chair: Carolina S Smaltz, PhD student Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz
Study Chair: Jose L Teixeira, Pharmacist Instituto de pesquisa Clinica Evandro Chagas
Study Chair: David J Hadad, PhD Federal University of Espirito Santo
Study Chair: Reynaldo Dietze, PhD Federal University of Espirito Santo
Study Chair: Moises Palaci, PhD Federal University of Espirito Santo
Oswaldo Cruz Foundation
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP