Pharmacokinetics of Low Dose Raltegravir

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study and compare the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients.

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

Details

• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Chulalongkorn University; National Healthcare Group Pte Ltd, Singapore
• Treatments: Raltegravir Potassium

Criteria

Inclusion Criteria:

• Signed informed consent

• Evidence of HIV infection

• Age> 18 years

• On RAL 400 mg BID containing HAART regimen with a VL < 50 copies for at least 3 months before enrollment

• Willing to adhere to the protocol requirements

Exclusion Criteria:

• Evidence of RAL resistance

• History of RAL allergy

• Use of concomitant medication that may interfere with the pharmacokinetics of RAL

• Current pregnancy or lactating or planning to get pregnant

• Active drug abuse or alcoholic

• Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.