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

HIV Infections Clinical Trial

— N2R  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483054
• Other study ID #: 210041000824904203
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2007
• Last updated: November 21, 2011
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: June 2009
• Source: Bamrasnaradura Infectious Diseases Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

Intervention

Drug:
• efavirenz
efavirenz 600 mg/day + stavudine + lamivudine
• nevirapine
nevirapine 400 mg/day + stavudine +lamivudine

Locations

Country	Name	City	State
Thailand	Bamrasnaradura Infectious Diseases Institute	Nonthaburi

Sponsors (3)

Lead Sponsor	Collaborator
Bamrasnaradura Infectious Diseases Institute	Chulalongkorn University, Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes