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

Bamrasnaradura Infectious Diseases Institute

Status and phase

Completed

Phase 3

Conditions

Tuberculosis

HIV Infections

Treatments

Drug: nevirapine

Drug: efavirenz

Study type

Interventional

Funder types

Other

Identifiers

NCT00483054

210041000824904203

Details and patient eligibility

About

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.

Enrollment

142 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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