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

The HIV Netherlands Australia Thailand Research Collaboration

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Drug: efavirenz

Study type

Interventional

Funder types

Other

Identifiers

NCT00476424

HIV-NAT 081

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No 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