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

NCT00483054 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2011-11-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

efavirenz

efavirenz 600 mg/day + stavudine + lamivudine

DRUG

nevirapine

nevirapine 400 mg/day + stavudine +lamivudine

Sponsors & Collaborators

  • Mahidol University

    collaborator OTHER

  • Chulalongkorn University

    collaborator OTHER

  • Bamrasnaradura Infectious Diseases Institute

    lead OTHER_GOV

Principal Investigators

  • Weerawat Manosuthi, MD · Bamrasnaradura Infectious Diseases Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-12-31
Completion
2010-12-31

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483054 on ClinicalTrials.gov