Efavirenz-Based Versus Nevirapine-Based Antiretroviral Therapy Among HIV-Infected Patients Receiving Rifampin
Information source: Bamrasnaradura Infectious Diseases Institute
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Tuberculosis
Intervention: efavirenz (Drug); nevirapine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bamrasnaradura Infectious Diseases Institute Official(s) and/or principal investigator(s):
Weerawat Manosuthi, MD, Principal Investigator, Affiliation: Bamrasnaradura Infectious Diseases Institute
Overall contact:
Weerawat - Manosuthi, MD, Phone: 662-590-3631, Email: idweerawat@yahoo.com
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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48, 96 and 144 weeks after initiation of antiretroviral treatment between the 2 groups
Secondary outcome: to compare CD4 response at 48, 96 and 144 weeks after initiation of antiretroviral treatment,
to compare adverse drugs reaction between the 2 groups
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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
Locations and Contacts
Weerawat - Manosuthi, MD, Phone: 662-590-3631, Email: idweerawat@yahoo.com
Bamrasnaradura Infectious Diseases Institute, Nonthaburi 11000, Thailand; Recruiting
Supeda Thongyen, MSc, Phone: 662-590-3631, Email: supeda_t@yahoo.com
Additional Information
Starting date: January 2007
Ending date: December 2010
Last updated: April 30, 2008
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