HIV InfectionsPhase 3N2RNCT00483054
Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
A Phase 3 study testing efavirenz and nevirapine in people with HIV Infections and Tuberculosis, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
Trial summary
The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4 weeks butt not exceed 16 weeks before enrolment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- efavirenz and nevirapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2007to Dec 2010
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Positive Serology for HIV-1
- Naïve to antiretroviral therapy
- Baseline CD4 cell counts <250 cells/mm3
- Diagnosed active tuberculosis by clinical features and/or positive acid fast stain and/or positive culture
- Received rifampicin at least 4 weeks but not exceed 16 weeks prior to enrollment
- Willing to participate and sign inform consent
Who cannot join
- Aspartate transferase enzymes (AST) or alanine transminase enzyme (ALT) >5 times of upper limit
- total bilirubin >3 times of upper limit
- serum creatinine) >2 times of upper limit
- pregnancy or lactation
- receiving immunosuppressive drugs
- receiving any drugs that may have drug-drug interaction with nevirapine and rifampicin
Show all 9Show fewer
- chronic alcoholic drunken and intravenous drug users
- Previously received single dose of nevirapine to prevent mother to child transmission
- positive for serum cryptococcal antigen
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Changwat Nonthaburi, 11000
About this study
The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4 weeks butt not exceed 16 weeks before enrolment. All patients receive the same backbone regimen of stavudine (30 mg/40 mg twice daily)+ lamivudie 150 mg twice daily. They are randomized to receive nevirapine 400 mg/day twice daily vs efavirenz 600 mg/day at bed time. All patients are followed through 144 weeks after initiation of antiviral therapy. The primary objective are to compare the proportion of patient who achieve undetectable plasma HIV-1RNA<50 copies/ml at week 48. The previous reports demonstrated that the standard doses of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis patients who receiving rifampicin even though plasma levels are somewhat reduced by rifampicin. However, there have been not been a randomized control trial to compare these two regimens. Thus, this trial will provide the efficacy data between these two regimens.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- efavirenz, nevirapine
- Keywords
- HIV, tuberculosis, efavirenz, nevirapine, rifampicin, co-infected HIV and tuberculosis patients
- Medical subject headings
- HIV Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efavirenzDrug
efavirenz 600 mg/day + stavudine + lamivudine
nevirapineDrug
nevirapine 400 mg/day + stavudine +lamivudine
| Study group | Role | What they receive |
|---|---|---|
| Efavirenz | Experimental | Efavirenz 600 mg/day + stavudine +lamivudine Receives: Drug: efavirenz |
| Nevirapine | Experimental | Nevirapine 400 mg/day + stavudine +lamivudine Receives: Drug: nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48 weeks after initiation of antiretroviral treatment between the 2 groups
Measured: 48 weeks
Secondary outcomes (1)
to compare CD4 response at 48, 96 and 144 weeks after initiation of antiretroviral treatment, to compare adverse drugs reaction between the 2 groups
Measured: 144 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bamrasnaradura Infectious Diseases Institute
- Sponsor type
- Other government
- Collaborators
- Mahidol University, Chulalongkorn University
- Investigators
- Weerawat Manosuthi, MD, Principal investigator, Bamrasnaradura Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483054
- Sponsor's protocol ID
- 210041000824904203
- Acronym
- N2R
- Status last verified
- Jun 2009
- First submitted
- 5 Jun 2007
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manosuthi W, Sungkanuparph S, Tantanathip P, Lueangniyomkul A, Mankatitham W, Prasithsirskul W, Burapatarawong S, Thongyen S, Likanonsakul S, Thawornwa U, Prommool V, Ruxrungtham K; N2R Study Team. A randomized trial comparing plasma drug concentrations and efficacies between 2 nonnucleoside reverse-transcriptase inhibitor-based regimens in HIV-infected patients receiving rifampicin: the N2R Study. Clin Infect Dis. 2009 Jun 15;48(12):1752-9. doi: 10.1086/599114.
PubMed 19438397
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
- ClinicalTrials.gov ID
- NCT00483054
- Acronym / sponsor ID
- N2R / 210041000824904203
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- HIV, tuberculosis, efavirenz, nevirapine, rifampicin, co-infected HIV and tuberculosis patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Bamrasnaradura Infectious Diseases InstituteOther government
- Collaborators
- Mahidol University, Chulalongkorn University
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jun 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.
The randomized controlled trial is conducted among antiretroviral naive co-infected HIV and tuberculosis patients who receiving rifampicin-based antituberculous regimen fro at least 4 weeks butt not exceed 16 weeks before enrolment. All patients receive the same backbone regimen of stavudine (30 mg/40 mg twice daily)+ lamivudie 150 mg twice daily. They are randomized to receive nevirapine 400 mg/day twice daily vs efavirenz 600 mg/day at bed time. All patients are followed through 144 weeks after initiation of antiviral therapy. The primary objective are to compare the proportion of patient who achieve undetectable plasma HIV-1RNA<50 copies/ml at week 48. The previous reports demonstrated that the standard doses of both nevirapine and efavirenz coulde be used among co-infected HIV and tuberculosis patients who receiving rifampicin even though plasma levels are somewhat reduced by rifampicin. However, there have been not been a randomized control trial to compare these two regimens. Thus, this trial will provide the efficacy data between these two regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efavirenz | Experimental | Drug: efavirenzEfavirenz 600 mg/day + stavudine +lamivudine |
| Nevirapine | Experimental | Drug: nevirapineNevirapine 400 mg/day + stavudine +lamivudine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-60 years
- Positive Serology for HIV-1
- Naïve to antiretroviral therapy
- Baseline CD4 cell counts <250 cells/mm3
- Diagnosed active tuberculosis by clinical features and/or positive acid fast stain and/or positive culture
Key exclusion criteria (9 listed)
- Aspartate transferase enzymes (AST) or alanine transminase enzyme (ALT) >5 times of upper limit
- total bilirubin >3 times of upper limit
- serum creatinine) >2 times of upper limit
- pregnancy or lactation
- receiving immunosuppressive drugs
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 |
|---|---|---|
| efavirenzefavirenz 600 mg/day + stavudine + lamivudine | Drug | Efavirenz |
| nevirapinenevirapine 400 mg/day + stavudine +lamivudine | Drug | Nevirapine |
Primary outcome
To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48 weeks after initiation of antiretroviral treatment between the 2 groups
Time frame: 48 weeks
1 secondary outcome
to compare CD4 response at 48, 96 and 144 weeks after initiation of antiretroviral treatment, to compare adverse drugs reaction between the 2 groups
Time frame: 144 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Derived from this study: PubMed 19438397Manosuthi W, Sungkanuparph S, Tantanathip P, Lueangniyomkul A, Mankatitham W, Prasithsirskul W, Burapatarawong S, Thongyen S, Likanonsakul S, Thawornwa U, Prommool V, Ruxrungtham K; N2R Study Team. A randomized trial comparing plasma drug concentrations and efficacies between 2 nonnucleoside reverse-transcriptase inhibitor-based regimens in HIV-infected patients receiving rifampicin: the N2R Study. Clin Infect Dis. 2009 Jun 15;48(12):1752-9. doi: 10.1086/599114.
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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.
Weerawat Manosuthi, MD principal investigator
Bamrasnaradura Infectious Diseases Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing efavirenz and nevirapine in people with HIV Infections and Tuberculosis, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48 weeks after initiation of antiretroviral treatment between the 2 groups (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483054, which also lists 1 linked publication.
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 22 Nov 2011.