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

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

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: efavirenz


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>400 mg EFV | Drug: efavirenz<br>* EFV 400 mg OD for 14 days EFV 600 mg OD for 14 days<br>|
| Active Comparator: 2<br>600 mg EFV | Drug: efavirenz<br>* EFV 400 mg OD for 14 days EFV 600 mg OD for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access efavirenz plasma level after discontinuation of this medication |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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once daily Efavirenz 400 mg, PK once daily Efavirenz 400 mg versus 600 mg, Treatment Experienced