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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

efavirenz

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring once daily Efavirenz 400 mg, PK once daily Efavirenz 400 mg versus 600 mg, Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

400 mg EFV

600 mg EFV

Outcomes

Primary Outcome Measures

Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration

Secondary Outcome Measures

Access efavirenz plasma level after discontinuation of this medication

Full Information

NCT ID

NCT00476424

First Posted

May 20, 2007

Last Updated

July 15, 2020

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Ministry of Education, Thailand

1. Study Identification

Unique Protocol Identification Number

NCT00476424

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Ministry of Education, Thailand

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

400 mg EFV

Arm Title

Arm Type

Active Comparator

Arm Description

600 mg EFV

Intervention Type

Drug

Intervention Name(s)

efavirenz

Intervention Description

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

Primary Outcome Measure Information:

Title

Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Access efavirenz plasma level after discontinuation of this medication

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kiat Ruxrungtham, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

12. IPD Sharing Statement

Links:

URL

http://www.hivnat.org

Description

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

Learn more about this trial

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

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