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

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration (Other)

Overall Status

Completed

CT.gov ID

NCT00476424

Collaborator

Ministry of Education, Thailand (Other)

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: efavirenz	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

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

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration [6 weeks]

Secondary Outcome Measures

Access efavirenz plasma level after discontinuation of this medication [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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