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

History of Changes

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:

MedlinePlus related topics: HIV/AIDS Tuberculosis

Drug Information available for: Rifampin Efavirenz

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

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:


Tuberculosis Actinomycetales Infections Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Efavirenz Rifampin Anti-Bacterial Agents Anti-Infective Agents Anti-Retroviral Agents	Antibiotics, Antitubercular Antitubercular Agents Antiviral Agents Enzyme Inhibitors Leprostatic Agents Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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