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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00476424

Enrollment

Registered

2007-05-22

Start date

2007-06-30

Completion date

2008-03-31

Last updated

2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

Brief summary

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

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.

Interventions

DRUGefavirenz

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Access efavirenz plasma level after discontinuation of this medication	4 weeks

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026