A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects

This study has been completed.
Sponsor:
Collaborator:
Commission on Higher Education, Ministry of Education
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476424
First received: May 20, 2007
Last updated: June 4, 2010
Last verified: June 2010

May 20, 2007
June 4, 2010
June 2007
March 2008   (final data collection date for primary outcome measure)
Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT00476424 on ClinicalTrials.gov Archive Site
Access efavirenz plasma level after discontinuation of this medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Access efavirenz plasma level after discontinuation of this medication [ Time Frame: 4 weeks ]
Not Provided
Not Provided
 
A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects
A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects

A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected subjects.

Efavirenz Pharmacokinetic evaluation supports once-daily dosing (T1/2 is 10-52 hours). The recommended dosage of efavirenz in combination with nucleoside reverse transcriptase inhibitor (NRTI) and/or protease inhibitor (PI) is 600mg orally, once daily.

In Thai populations, many ARV levels are very high. We believe that 600 mg efavirenz is too high for Thai people and would like to see the pharmacokinetic data and safety and efficacy of efavirenz at 400 mg.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: efavirenz
EFV 400 mg OD for 14 days EFV 600 mg OD for 14 days
  • Active Comparator: 1
    400 mg EFV
    Intervention: Drug: efavirenz
  • Active Comparator: 2
    600 mg EFV
    Intervention: Drug: efavirenz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years of age or older with HIV-1 infection
  • Who are on stable PI-based highly active antiretroviral therapy and have HIV-1 RNA <50 copies/ml within 6 months.
  • No active opportunistic infection.
  • Sexually active subjects must be willing to use an effective form of birth control.
  • Able to provide written informed consent.

Exclusion Criteria:

  • Pregnant or breast-feeding females are excluded.
  • Inability to understand the nature and extent of the study and the procedures required.
  • ALT/ AST more than 5x upper limit
  • Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
  • Use of concomitant medication that may interfere with the pharmacokinetics of efavienz
  • History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
  • Active drug abuse
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00476424
HIV-NAT 081
Yes
Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
Commission on Higher Education, Ministry of Education
Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

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