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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476424
• Other study ID #: HIV-NAT 081
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: March 2008

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• efavirenz
EFV 400 mg OD for 14 days EFV 600 mg OD for 14 days

Locations

Country	Name	City	State
Thailand	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Ministry of Education, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration		6 weeks
Secondary	Access efavirenz plasma level after discontinuation of this medication		4 weeks

External Links

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