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
  Purpose

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


Condition Intervention Phase
Tuberculosis
HIV Infections
Drug: efavirenz
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anti-retroviral Efficacy, Tolerance and Other Pharmacologic Interactions of the Non Nucleoside Analog Efavirenz in Association With Rifampicin to Treat Tuberculosis and AIDS

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Immunologic reconstitution Genotyping resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: January 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Efavirenz 800 mg (tablet) QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin
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
Active Comparator: 1
Efavirenz 600 mg (tablet) QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533390

Locations
Brazil
Universidade Federal do Espirito Santo
Vitoria, Espirito Santo, Brazil
FIOCRUZ Instituto de Pesquisa Clinica Evandro Chagas
Rio de Janeiro, Brazil, 21040-900
Sponsors and Collaborators
Oswaldo Cruz Foundation
Conselho Nacional de Desenvolvimento Científico e Tecnológico
UNODOC
Investigators
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
  More Information

No publications provided

Responsible Party: Valeria Cavalcanti Rolla, MD, PhD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00533390     History of Changes
Other Study ID Numbers: CAAE-0017.1.009.000-03
Study First Received: September 19, 2007
Last Updated: December 28, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Oswaldo Cruz Foundation:
efavirenz
tuberculosis
AIDS
rifampicin
efficacy
safety
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Efavirenz
Rifampin
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents

ClinicalTrials.gov processed this record on October 16, 2014