A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects

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