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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Cytochrome P2B6 on Efavirenz Dose in HIV-infected Thai Patients

NCT02421289

Cytochrome P-450 CYP2B6 Efavirenz HIV

UNKNOWN PHASE1

Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.

NCT01011413

HIV Infections

COMPLETED PHASE3

Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients

NCT04596488

HIV-1-infection

COMPLETED NA

Three Month Course of Anti-HIV Medications for People Recently Infected With HIV

NCT00087464

HIV Infections

WITHDRAWN NA

Efavirenz (EFV) Intensification

NCT07193875

HIV

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

400 mg EFV

Group Type ACTIVE_COMPARATOR

efavirenz

Intervention Type DRUG

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

2

600 mg EFV

Group Type ACTIVE_COMPARATOR

efavirenz

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

efavirenz

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No