TuberculosisPhase 4IPEC-EFVNCT00533390
Randomized Clinical Trial to Assess the Efficacy and Safety of Concomitant Use of Rifampicin and Efavirenz 600 X 800mg
A Phase 4 study testing efavirenz in people with Tuberculosis and HIV Infections, run by Oswaldo Cruz Foundation at 2 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, HIV Infections
- What is being tested?
- efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2007to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with tuberculosis diagnosis, HIV positive.
- Agreement to avoid not allowed drugs during the trial, agreement to participate in the study (informed consent)
Who cannot join
- Active liver disease
- Pregnancy or breast feeding
- CD4 counts >350
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
FIOCRUZ Instituto de Pesquisa Clinica Evandro Chagas
Rio de Janeiro, Rio de Janeiro, 21040-900
Universidade Federal do Espirito Santo
Vitória, Espírito Santo
About this study
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
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
Read the 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
- Conditions
- Tuberculosis, HIV Infections
- Being tested
- efavirenz
- Keywords
- efavirenz, tuberculosis, AIDS, rifampicin, efficacy, safety, Treatment Naive
- Medical subject headings
- Tuberculosis, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efavirenzDrug
Also called Stocrin, Sustiva
600mg X 800mg QID during TB therapy with rifampicin associated with other antituberculosis drugs in patients concomitant treated for tuberculosis and AIDS
| Study group | Role | What they receive |
|---|---|---|
| EFAVIRENZ 800mg | Experimental | Efavirenz 800 mg (tablet) PO QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin Receives: Drug: efavirenz |
| EFAVIRENZ 600mg | Active comparator | Efavirenz 600 mg (tablet) PO QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin Receives: Drug: efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with viral load < 80 at the end of tuberculosis therapy proportion of adverse events in each group
Measured: 6 months
Secondary outcomes (1)
Immunologic reconstitution Genotyping resistance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJan 2007
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Lack of financial support and low inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Responsible party
- Principal investigator, Valeria Cavalcanti Rolla, Oswaldo Cruz Foundation
- Investigators
- Valeria C Rolla, MD DSc, Principal investigator, Instituto de Pesquisa Clinica Evandro Chagas, FiocruzMaria Cristina S Lourenço, MSc, Study chair, Instituto de Pesquisa Clinica Evandro Chagas, FiocruzFlávia M Sant'Anna, MSc, Study chair, Instituto de Pesquisa Clinica Evandro Chagas, FiocruzMariza G Morgado, DSc, Study chair, Instituto Oswaldo Cruz, FiocruzPedro E Americano do Brasil, MD MSc, Study chair, Instituto de Pesquisa Clinica Evandro Chagas, FiocruzCarolina S Smaltz, PhD student, Study chair, Instituto de Pesquisa Clinica Evandro Chagas, FiocruzJose L Teixeira, Pharmacist, Study chair, Instituto de pesquisa Clinica Evandro ChagasDavid J Hadad, PhD, Study chair, Federal University of Espirito Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533390
- Sponsor's protocol ID
- CAAE-0017.1.009.000-03
- Acronym
- IPEC-EFV
- Status last verified
- Nov 2015
- First submitted
- 19 Sep 2007
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00533390
- Acronym / sponsor ID
- IPEC-EFV / CAAE-0017.1.009.000-03
- Conditions
- Tuberculosis, HIV Infections
- Keywords
- efavirenz, tuberculosis, AIDS, rifampicin, efficacy, safety, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of financial support and low inclusion rate
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- Jan 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFAVIRENZ 800mg | Experimental | Drug: efavirenzEfavirenz 800 mg (tablet) PO QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin |
| EFAVIRENZ 600mg | Active comparator | Drug: efavirenzEfavirenz 600 mg (tablet) PO QD during 5 months associated with two nucleoside analogs during tuberculosis therapy with rifampicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with tuberculosis diagnosis, HIV positive.
- Agreement to avoid not allowed drugs during the trial, agreement to participate in the study (informed consent)
Key exclusion criteria (3 listed)
- Active liver disease
- Pregnancy or breast feeding
- CD4 counts >350
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| efavirenzAlso: Stocrin, Sustiva600mg X 800mg QID during TB therapy with rifampicin associated with other antituberculosis drugs in patients concomitant treated for tuberculosis and AIDS | Drug | EFAVIRENZ 600mg, EFAVIRENZ 800mg |
Primary outcome
proportion of patients with viral load < 80 at the end of tuberculosis therapy proportion of adverse events in each group
Time frame: 6 months
1 secondary outcome
Immunologic reconstitution Genotyping resistance
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of financial support and low inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria C Rolla, MD DSc principal investigator
Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz
Maria Cristina S Lourenço, MSc study chair
Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz
Flávia M Sant'Anna, MSc study chair
Instituto de Pesquisa Clinica Evandro Chagas, Fiocruz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing efavirenz in people with Tuberculosis and HIV Infections, run by Oswaldo Cruz Foundation at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of financial support and low inclusion rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with viral load < 80 at the end of tuberculosis therapy proportion of adverse events in each group (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.