Pharmacokinetics of Low Dose Raltegravir

HIV Infections Clinical Trial

Official title:

Pharmacokinetics of Low Dose Raltegravir

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159132
• Other study ID #: HIV-NAT 127
• Status: Completed
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Thailand	HIV-NAT	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Chulalongkorn University, National Healthcare Group Pte Ltd, Singapore

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetics of RAL in Thais	To assess AUC, Cmax, Cmin, T 1/2, clearance of RAL at dose of 400 mg BID, 800 mg OD, 400 mg OD in Thai	29 days

External Links

•   HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)