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
  Purpose

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 Intervention Phase
HIV Infections
Tuberculosis
Drug: efavirenz
Drug: nevirapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin

Resource links provided by NLM:


Further study details as provided by Bamrasnaradura Infectious Diseases Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 142
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483054

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

No publications provided by Bamrasnaradura Infectious Diseases Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Disease Control, Ministry of Public Health
ClinicalTrials.gov Identifier: NCT00483054     History of Changes
Other Study ID Numbers: 210041000824904203
Study First Received: June 5, 2007
Last Updated: November 21, 2011
Health Authority: Thailand: Ministry of Public Health

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Rifampin
Nevirapine
Efavirenz
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014