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Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin

NCT ID: NCT00483054

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections Tuberculosis

Keywords

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HIV tuberculosis efavirenz nevirapine rifampicin co-infected HIV and tuberculosis patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Efavirenz

Efavirenz 600 mg/day + stavudine +lamivudine

Group Type EXPERIMENTAL

efavirenz

Intervention Type DRUG

efavirenz 600 mg/day + stavudine + lamivudine

Nevirapine

Nevirapine 400 mg/day + stavudine +lamivudine

Group Type EXPERIMENTAL

nevirapine

Intervention Type DRUG

nevirapine 400 mg/day + stavudine +lamivudine

Interventions

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efavirenz

efavirenz 600 mg/day + stavudine + lamivudine

Intervention Type DRUG

nevirapine

nevirapine 400 mg/day + stavudine +lamivudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* chronic alcoholic drunken and intravenous drug users
* Previously received single dose of nevirapine to prevent mother to child transmission
* positive for serum cryptococcal antigen
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role collaborator

Bamrasnaradura Infectious Diseases Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ministry of Public Health

Principal Investigators

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Weerawat Manosuthi, MD

Role: PRINCIPAL_INVESTIGATOR

Bamrasnaradura Infectious Diseases Institute

Locations

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Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 19438397 (View on PubMed)

Other Identifiers

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210041000824904203

Identifier Type: -

Identifier Source: org_study_id