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NCT Number: NCT00483054

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.

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Key information

Conditions

HIV Infections Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efavirenz

Drug

efavirenz 600 mg/day + stavudine + lamivudine

Nevirapine

Drug

nevirapine 400 mg/day + stavudine +lamivudine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bamrasnaradura Infectious Diseases Institute

Other Gov

Collaborators

  • Chulalongkorn University
  • Mahidol University

Registry information

Acronym: N2R

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Jun 6, 2007
Registry last updated
Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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