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Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin (N2R)

This study has been completed.
Sponsor:
Collaborators:
Mahidol University
Chulalongkorn University
Information provided by:
Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier:
NCT00483054
First received: June 5, 2007
Last updated: November 21, 2011
Last verified: June 2009

June 5, 2007
November 21, 2011
January 2007
December 2008   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48, 96 and 144 weeks after initiation of antiretroviral treatment between the 2 groups [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00483054 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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 ]
Not Provided
Not Provided
 
Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Tuberculosis
  • Drug: efavirenz
    efavirenz 600 mg/day + stavudine + lamivudine
  • Drug: nevirapine
    nevirapine 400 mg/day + stavudine +lamivudine
  • Experimental: Efavirenz
    Efavirenz 600 mg/day + stavudine +lamivudine
    Intervention: Drug: efavirenz
  • Experimental: Nevirapine
    Nevirapine 400 mg/day + stavudine +lamivudine
    Intervention: Drug: nevirapine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
December 2010
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00483054
210041000824904203
Yes
Department of Disease Control, Ministry of Public Health
Bamrasnaradura Infectious Diseases Institute
  • Mahidol University
  • Chulalongkorn University
Principal Investigator: Weerawat Manosuthi, MD Bamrasnaradura Infectious Diseases Institute
Bamrasnaradura Infectious Diseases Institute
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP