NCT01159132

Pharmacokinetics of Low Dose Raltegravir

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 PK collection for RAL 400 mg BID and the blood samples will be drawn at T = 0.0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0, and 12.0 hour post medication. All 24 subjects will be randomised (1:1) to either Group A (RAL 400 mg OD) or Group B (RAL 800 mg OD) for 14 days. On day 15, a second 24 hour intensive PK will be carried out and the blood samples will be drawn. After 2nd intensive PK, the subjects will switch to the other dosing regimen. Subjects in group A will receive RAL 800 mg OD and group B will receive RAL 400 mg OD for another 14 days. On day 29, the third 24 hour intensive PK will be carried out. After the 3rd intensive PK, all 24 subjects will be switched back to the initial regimen of RAL 400 mg BID.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	raltegravir	12 hour PK will be done on day 1 while subjects is on stable regimen with RAL 400 mg BID. After performing intensive PK, subjects will be randomized to either group A (RAL 400 mg OD) or B (RAL 800 mg OD) for 14 days and on day 15, a second 24 hour full PK will be carried out. After the intensive PK, subjects in both the groups will switched to the other dosing regimen, group A (RAL 800 mg OD) and B (RAL 400 mg OD) for another 14 days and on day 29, the third 24 hour full PK will be carried out.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-07-09
• Last updated: 2020-07-17

Locations

1 site across 1 country: Thailand