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:

ClinicalTrials.gov Identifier:

NCT00533390

First Posted: September 21, 2007

Last Update Posted: November 10, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Ministry of Health, Brazil

Information provided by (Responsible Party):

Valeria Cavalcanti Rolla, Oswaldo Cruz Foundation

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 Intervention Model: Parallel Assignment Masking: None (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 Valeria Cavalcanti Rolla, 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 ]

Secondary Outcome Measures:

Immunologic reconstitution Genotyping resistance [ Time Frame: 6 months ]


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: EFAVIRENZ 800mg Efavirenz 800 mg (tablet) PO 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: EFAVIRENZ 600mg Efavirenz 600 mg (tablet) PO 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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Ministry of Health, Brazil

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


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
First Submitted:	September 19, 2007
First Posted:	September 21, 2007
Last Update Posted:	November 10, 2015
Last Verified:	November 2015

Keywords provided by Valeria Cavalcanti Rolla, Oswaldo Cruz Foundation:


efavirenz tuberculosis AIDS rifampicin	efficacy safety Treatment Naive

Additional relevant MeSH terms:


HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System 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 Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antibiotics, Antitubercular

HIV Infections
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System 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
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Antibiotics, Antitubercular

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