Pharmacokinetics of Low Dose Raltegravir

This study has been completed.
Sponsor:
Collaborators:
National Healthcare Group Pte Ltd, Singapore
Chulalongkorn University
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT01159132
First received: June 9, 2010
Last updated: October 29, 2011
Last verified: October 2011

June 9, 2010
October 29, 2011
April 2010
December 2010   (final data collection date for primary outcome measure)
pharmacokinetics of RAL in Thais [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01159132 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics of Low Dose Raltegravir
Pharmacokinetics of Low Dose Raltegravir

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
HIV Infections
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.
  • Active Comparator: 1
    RAL 400 mg OD
    Intervention: Drug: raltegravir
  • Active Comparator: 2
    RAL 800 mg OD
    Intervention: Drug: raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01159132
HIV-NAT 127
Yes
The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
  • National Healthcare Group Pte Ltd, Singapore
  • Chulalongkorn University
Principal Investigator: Jintanat Ananworanich, MD, PhD The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP