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

Sponsor

Bamrasnaradura Infectious Diseases Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00483054

Collaborator

Mahidol University (Other), Chulalongkorn University (Other)

142

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jan 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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

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

Outcome Measures

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 [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 [144 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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