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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration

Collaborator
Ministry of Education, Thailand

Information provided by (Responsible Party)
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
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

Drug : efavirenz
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects

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

Primary Outcome Measures

  • Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration [ Time Frame: 6 weeks ]
Secondary Outcome Measures:
  • Access efavirenz plasma level after discontinuation of this medication [ Time Frame: 4 weeks ]

Enrollment: 28
Study Start Date: June 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: 1
400 mg EFV
Drug: efavirenz

EFV 400 mg OD for 14 days EFV 600 mg OD for 14 days

Active Comparator: 2
600 mg EFV
Drug: efavirenz

EFV 400 mg OD for 14 days EFV 600 mg OD for 14 days

Detailed Description:

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476424

Locations

Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Bangkok, Thailand, 10330

Sponsors and Collaborators

The HIV Netherlands Australia Thailand Research Collaboration
Ministry of Education, Thailand

Investigators

Principal Investigator: Kiat Ruxrungtham, MD The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
More Information

More Information

Additional Information:

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

Responsible Party: Kiat Ruxrungtham, HIV-NAT  
ClinicalTrials.gov Identifier: NCT00476424   History of Changes  
Other Study ID Numbers: HIV-NAT 081  
Study First Received: May 20, 2007  
Last Updated: June 4, 2010  

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:

once daily Efavirenz 400 mg
PK once daily Efavirenz 400 mg versus 600 mg
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Efavirenz

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.