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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00483054
Recruitment Status : Completed
First Posted : June 6, 2007
Last Update Posted : November 22, 2011
Mahidol University
Chulalongkorn University
Information provided by:
Bamrasnaradura Infectious Diseases Institute

Brief 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. 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.

Condition or disease Intervention/treatment Phase
HIV Infections Tuberculosis Drug: efavirenz Drug: nevirapine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
Study Start Date : January 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Efavirenz
Efavirenz 600 mg/day + stavudine +lamivudine
Drug: efavirenz
efavirenz 600 mg/day + stavudine + lamivudine

Experimental: Nevirapine
Nevirapine 400 mg/day + stavudine +lamivudine
Drug: nevirapine
nevirapine 400 mg/day + stavudine +lamivudine

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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 [ Time Frame: 144 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00483054

Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
Bamrasnaradura Infectious Diseases Institute
Mahidol University
Chulalongkorn University
Principal Investigator: Weerawat Manosuthi, MD Bamrasnaradura Infectious Diseases Institute

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Department of Disease Control, Ministry of Public Health Identifier: NCT00483054     History of Changes
Other Study ID Numbers: 210041000824904203
First Posted: June 6, 2007    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: June 2009

Keywords provided by Bamrasnaradura Infectious Diseases Institute:
co-infected HIV and tuberculosis patients

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors