A randomised, double-blind, placebo-controlled, clinical trial to compare the safety and efficacy of reduced dose efavirenz (EFV) with standard dose EFV plus two nucleotide reverse transcriptase inhibitors (N(t)RTI) in antiretroviral-naïve Human Immunodeficiency virus (HIV)-infected individuals over 96 weeks.
- Conditions
- HIV infectionInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12610001097033
- Lead Sponsor
- ational Centre for HIV Epidemiology and Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 630
*HIV-1 positive by licensed diagnostic test
*aged >16 years of age (or minimum age as determined by local regulations or as legal requirements dictate)
*50 < CD4 <350 cells/microlitres or previous aquired immune deficiency syndrome-defining illness
*HIV RNA greater than or equal to 1000 copies/mL
*no prior exposure to antiretrovirals (including short course antiretrovirals for preventing mother to child transmission)
*calculated creatinine clearance (CLCr) must be greater than or equal to 50 mL/min (Cockcroft-Gault formula)
*provision of written informed consent.
*the following laboratory values:
*absolute neutrophil count (ANC) <500 cells/microlitre
*hemoglobin <7.0 g/dL
*platelet count <50,000 cells/microlitre
*alanine aminotransferase and/or aspartate aminotransferase >5 x upper limit of normal
*pregnant women or nursing mothers
*active opportunistic or malignant disease not under adequate control
*use of immunomodulators within 30 days prior to screening
*use of any prohibited medications
*current alcohol or illicit substance use that might adversely affect study participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method