Status:
COMPLETED
Pharmacokinetics of Low Dose Raltegravir
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
National Healthcare Group Pte Ltd, Singapore
Chulalongkorn University
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Twenty four HIV-infected volunteers on stable doses of RAL 400 mg BID for at least 3 months and with undetectable viral load will be enrolled. On Day 1, all 24 subjects will attend the first intensive...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01159132
Start Date
April 1 2010
End Date
December 1 2010
Last Update
July 17 2020
Active Locations (1)
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1
HIV-NAT
Bangkok, Thailand, 10330