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Pharmacokinetics of Low Dose Raltegravir

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ClinicalTrials.gov Identifier: NCT01159132
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : November 1, 2011
Sponsor:
Collaborators:
National Healthcare Group Pte Ltd, Singapore
Chulalongkorn University
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: raltegravir Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Pharmacokinetics of Low Dose Raltegravir
Study Start Date : April 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. pharmacokinetics of RAL in Thais [ Time Frame: 29 days ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT01159132     History of Changes
Other Study ID Numbers: HIV-NAT 127
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: October 2011

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action