A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects
Information source: The HIV Netherlands Australia Thailand Research Collaboration
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: efavirenz (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: The HIV Netherlands Australia Thailand Research Collaboration Official(s) and/or principal investigator(s):
Kiat Ruxrungtham, MD, Principal Investigator, Affiliation: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Summary
A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected
subjects.
Clinical Details
Official title: A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects
Study design: Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration
Secondary outcome: Access efavirenz plasma level after discontinuation of this medication
Detailed description:
Efavirenz Pharmacokinetic evaluation supports once-daily dosing (T1/2 is 10-52 hours). The
recommended dosage of efavirenz in combination with nucleoside reverse transcriptase
inhibitor (NRTI) and/or protease inhibitor (PI) is 600mg orally, once daily.
In Thai populations, many ARV levels are very high. We believe that 600 mg efavirenz is too
high for Thai people and would like to see the pharmacokinetic data and safety and efficacy
of efavirenz at 400 mg.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age > 18 years of age or older with HIV-1 infection
- Who are on stable PI-based highly active antiretroviral therapy and have HIV-1 RNA <50
copies/ml within 6 months.
- No active opportunistic infection.
- Sexually active subjects must be willing to use an effective form of birth control.
- Able to provide written informed consent.
Exclusion Criteria:
- Pregnant or breast-feeding females are excluded.
- Inability to understand the nature and extent of the study and the procedures
required.
- ALT/ AST more than 5x upper limit
- Relevant history or current condition, illness that might interfere with drug
absorption, distribution, metabolism or excretion.
- Use of concomitant medication that may interfere with the pharmacokinetics of
efavienz
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which
may be employed in the study.
- Active drug abuse
Locations and Contacts
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok 10330, Thailand
Additional Information
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Starting date: June 2007
Ending date: March 2008
Last updated: March 13, 2008
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