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

NCT00483054 | Completed Phase 3 DMC

• 1 other identifier: 210041000824904203
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Tuberculosis

Keywords

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

Outcome Measures

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

  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

  144 weeks

Study Arms (2)

Efavirenz

EXPERIMENTAL

Efavirenz 600 mg/day + stavudine +lamivudine

Drug: efavirenz

Nevirapine

EXPERIMENTAL

Nevirapine 400 mg/day + stavudine +lamivudine

Drug: nevirapine

Interventions

efavirenz DRUG

efavirenz 600 mg/day + stavudine + lamivudine

Efavirenz

nevirapine DRUG

nevirapine 400 mg/day + stavudine +lamivudine

Nevirapine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bamrasnaradura Infectious Diseases Institute: lead
• Mahidol University: collaborator
• Chulalongkorn University: collaborator

Study Sites (1)

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

Location

Related Publications (1)

• Manosuthi W, Sungkanuparph S, Tantanathip P, Lueangniyomkul A, Mankatitham W, Prasithsirskul W, Burapatarawong S, Thongyen S, Likanonsakul S, Thawornwa U, Prommool V, Ruxrungtham K; N2R Study Team. A randomized trial comparing plasma drug concentrations and efficacies between 2 nonnucleoside reverse-transcriptase inhibitor-based regimens in HIV-infected patients receiving rifampicin: the N2R Study. Clin Infect Dis. 2009 Jun 15;48(12):1752-9. doi: 10.1086/599114.

  PMID: 19438397 DERIVED

MeSH Terms

Conditions

HIV Infections; Tuberculosis

Interventions

efavirenz; Nevirapine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Weerawat Manosuthi, MD

  Bamrasnaradura Infectious Diseases Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 5, 2007
• First Posted: June 6, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2010
• Last Updated: November 22, 2011

Record last verified: 2009-06

Locations

TH (1)