Pharmacokinetics of Low Dose Raltegravir - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: raltegravir	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Pharmacokinetics of Low Dose Raltegravir

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Raltegravir Raltegravir potassium

U.S. FDA Resources

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:

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

Estimated Enrollment:	24
Study Start Date:	April 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 RAL 400 mg OD	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: 2 RAL 800 mg OD	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.

Arms

Assigned Interventions

Active Comparator: 1

RAL 400 mg OD

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: 2

RAL 800 mg OD

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159132

Locations

Thailand
HIV-NAT
Bangkok, Thailand, 10330

Sponsors and Collaborators

The HIV Netherlands Australia Thailand Research Collaboration

National Healthcare Group Pte Ltd, Singapore

Chulalongkorn University

Investigators

Principal Investigator:

Jintanat Ananworanich, MD, PhD

The HIV Netherlands Australia Thailand Research Collaboration

More Information

Additional Information:

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT01159132 History of Changes
Other Study ID Numbers:	HIV-NAT 127
Study First Received:	June 9, 2010
Last Updated:	October 29, 2011
Health Authority:	Thailand: Ethical Committee

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

pharmacokinetics
low dose raltegravir
HIV
To study the pharmacokinetics profile of low dose raltegravir (RAL) (400mg OD and 800mg OD) and standard dose of 400mg BID in Thai HIV-infected patients.

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013