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

NCT00476424 | Completed Phase 2 DMC

• 1 other identifier: HIV-NAT 081
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (1)

• Access efavirenz plasma level after discontinuation of this medication

  4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

400 mg EFV

Drug: efavirenz

2

ACTIVE COMPARATOR

600 mg EFV

Drug: efavirenz

Interventions

efavirenz DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The HIV Netherlands Australia Thailand Research Collaboration: lead
• Ministry of Education, Thailand: collaborator

Study Sites (1)

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

Bangkok, 10330, Thailand

Location

Related Links

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

MeSH Terms

Conditions

HIV Infections

Interventions

efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Kiat Ruxrungtham, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2007
• First Posted: May 22, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

TH (1)