Pharmacokinetics of Low Dose Raltegravir

NCT01159132 | Completed Phase 2 DMC

• 1 other identifier: HIV-NAT 127
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

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.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

RAL 400 mg OD

Drug: raltegravir

2

ACTIVE COMPARATOR

RAL 800 mg OD

Drug: raltegravir

Interventions

raltegravir DRUG

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• National Healthcare Group Pte Ltd, Singapore: collaborator
• Chulalongkorn University: collaborator

Study Sites (1)

HIV-NAT

Bangkok, 10330, Thailand

Location

Related Links

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

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jintanat Ananworanich, MD, PhD

  The HIV Netherlands Australia Thailand Research Collaboration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: July 9, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (1)