Clinical trial NCT00483054: Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
Official title: Efavirenz-based Versus Nevirapine-based Antiretroviral Therapy Among HIV-infected Patients Receiving Rifampin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Tuberculosis
Keywords: HIV
tuberculosis
efavirenz
nevirapine
rifampicin
co-infected HIV and tuberculosis patients
Lead sponsor: Bamrasnaradura Infectious Diseases Institute
Sponsor class: OTHER_GOV
Collaborators: name: Mahidol University
name: Chulalongkorn University
First posted: 2007-06-06
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 48 weeks
Secondary outcomes:
measure: to compare CD4 response at 48, 96 and 144 weeks after initiation of antiretroviral treatment, to compare adverse drugs reaction between the 2 groups
timeFrame: 144 weeks
Other outcomes:
Locations:
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Diseases Institute
Study officials:
affiliation: Bamrasnaradura Infectious Diseases Institute
name: Weerawat Manosuthi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.