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

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

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: efavirenz

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The HIV Netherlands Australia Thailand Research Collaboration
• Collaborators: Ministry of Education, Thailand
• Investigators: Principal Investigator: Kiat Ruxrungtham, MD, The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)

Publications and helpful links

Helpful Links

• The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: May 20, 2007
• First Submitted That Met QC Criteria: May 21, 2007
• First Posted (Estimate): May 22, 2007

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Treatment Experienced; once daily Efavirenz 400 mg; PK once daily Efavirenz 400 mg versus 600 mg
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Efavirenz
• Other Study ID Numbers: HIV-NAT 081