A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects
This study has been completed.
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborator:
Commission on Higher Education, Ministry of Education
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00476424
First received: May 20, 2007
Last updated: June 4, 2010
Last verified: June 2010
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Purpose
A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: efavirenz |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Efavirenz
U.S. FDA Resources
Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:
Primary Outcome Measures:
- Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Access efavirenz plasma level after discontinuation of this medication [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 28 |
| Study Start Date: | June 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476424
Locations
| Thailand | |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) | |
| Bangkok, Thailand, 10330 | |
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Commission on Higher Education, Ministry of Education
Investigators
| Principal Investigator: | Kiat Ruxrungtham, MD | The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kiat Ruxrungtham, HIV-NAT |
| ClinicalTrials.gov Identifier: | NCT00476424 History of Changes |
| Other Study ID Numbers: | HIV-NAT 081 |
| Study First Received: | May 20, 2007 |
| Last Updated: | June 4, 2010 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
|
once daily Efavirenz 400 mg PK once daily Efavirenz 400 mg versus 600 mg Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Efavirenz Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 23, 2013