A randomised, double-blind, placebo-controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus 2N(t)RTI in antiretroviral-naive HIV-infected individuals over 96 weeks. Encore1 intensive pharmacokinetics sub-study
Phase 3
Active, not recruiting
- Conditions
- HIV infectionInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12612000263897
- Lead Sponsor
- Kirby Institute/University of New South Wales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Main study participants at selected sites are eligible:
provide written sub-study consent at or before week 0
taken randomized study drugs for at least 4 weeks but less than 8 weeks
taken EFV in the evening for at least 7 days
taken all EFV doses over the 3 preceding days.
Exclusion Criteria
nil
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the pharmacokinetic parameters of EFV determined from blood collected over a 24-hour dosing interval in blinded samples from participants taking either EFV 600 mg or 400 mg once daily in combination with Truvada.[48 weeks]
- Secondary Outcome Measures
Name Time Method To compare the safety and tolerability of EFV 400 mg versus 600 mg given once daily by between-group comparison of adverse event and serious adverse event frequency, clinical assessment and results of DASS-21 and subject experience questionnaires.<br>Adverse events are those commonly observed with EFV therapy and included central nervous system events such as dizziness, vivid dreams, poor of concentration. Events will be assessed by clinical examination and use of questionnaires as above.[48 weeks];To compare pharmacokinetic parameters (AUC0-24, t1/2, Cmax, Tmax, Cmin, CL/F) between EFV 400 mg and 600 mg dosed once daily.[48 weeks]