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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborator: Ministry of Education, Thailand
• Treatments: Efavirenz

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