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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Bamrasnaradura Infectious Diseases Institute

Collaborator
Mahidol University
Chulalongkorn University

Information provided by (Responsible Party)
Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier
NCT00483054

First received: June 5, 2007
Last updated: November 21, 2011
Last Verified: June 2009
History of Changes
Purpose

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
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

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 ]
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 ]

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

Eligibility

Ages Eligible for Study: 18 Years to 60 Years  
Sexes Eligible for Study: All  
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

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

More Information


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  

Keywords provided by Bamrasnaradura Infectious Diseases Institute:

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

Additional relevant MeSH terms:
HIV Infections
Tuberculosis
Lamivudine
Efavirenz
Nevirapine
Stavudine
Rifampin

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.