Randomized Clinical Trial to Assess the Efficacy and Safety of Concomitant Use of Rifampicin and Efavirenz 600 X 800mg (IPEC-EFV)
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ClinicalTrials.gov Identifier: NCT00533390 |
Recruitment Status
:
Terminated
(Lack of financial support and low inclusion rate)
First Posted
: September 21, 2007
Last Update Posted
: November 10, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tuberculosis HIV Infections | Drug: efavirenz | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 130 participants |
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 |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: EFAVIRENZ 800mg
Efavirenz 800 mg (tablet) PO QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin
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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:
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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:
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- proportion of patients with viral load < 80 at the end of tuberculosis therapy proportion of adverse events in each group [ Time Frame: 6 months ]
- Immunologic reconstitution Genotyping resistance [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Brazil | |
Universidade Federal do Espirito Santo | |
Vitoria, Espirito Santo, Brazil | |
FIOCRUZ Instituto de Pesquisa Clinica Evandro Chagas | |
Rio de Janeiro, Brazil, 21040-900 |
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 |
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 Posted: | September 21, 2007 Key Record Dates |
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 |