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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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 |
- 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 ]
- 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:
|
|
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:
|
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 |
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| 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 | Universidade Federal do Espirito Santo |
| Study Chair: | Reynaldo Dietze, PhD | Universidade Federal do Espirito Santo |
| Study Chair: | Moises Palaci, PhD | Universidade Federal do 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 Rifampin Efavirenz Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antitubercular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Nucleic Acid Synthesis Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on March 03, 2013
