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

This study has been completed.

First Received: May 20, 2007 Last Updated: March 13, 2008 History of Changes

Sponsor:	The HIV Netherlands Australia Thailand Research Collaboration
Collaborator:	Commission on Higher Education, Ministry of Education
Information provided by:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT00476424

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Efavirenz

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Access efavirenz plasma level after discontinuation of this medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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
1: Active Comparator 400 mg EFV	Drug: efavirenz EFV 400 mg OD for 14 days EFV 600 mg OD for 14 days
2: Active Comparator 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Commission on Higher Education, Ministry of Education

Investigators

Principal Investigator:

Kiat Ruxrungtham, MD

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

More Information

Additional Information:

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

No publications provided

Responsible Party:	HIV-NAT ( Kiat Ruxrungtham )
Study ID Numbers:	HIV-NAT 081
Study First Received:	May 20, 2007
Last Updated:	March 13, 2008
ClinicalTrials.gov Identifier:	NCT00476424 History of Changes
Health Authority:	Thailand: Ethical Committee

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:

Anti-Infective Agents
Efavirenz
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010