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 HIV-infected individuals over 96 weeks. - Encore1

Phase 1

• Conditions: HIV infection; MedDRA version: 14.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2009-013795-44-GB
• Lead Sponsor: ational Centre in HIV Epidemiology and Clinical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-16
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 630

Inclusion Criteria

• 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/µL or previous AIDS-defining illness
• HIV RNA =1000 copies/mL
• no prior exposure to ART (including short course ARVs for preventing MTCT)
• calculated creatinine clearance (CLCr) = 50 mL/min (Cockcroft-Gault formula)
• provision of written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• the following laboratory values:
- absolute neutrophil count (ANC) <500 cells/µL
- hemoglobin <7.0 g/dL
- platelet count <50,000 cells/µL
- AST and/or ALT >5 x ULN
• 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the safety and efficacy of standard (600mg qd) versus reduced dose (400mg qd) EFV as part of initial combination antiretroviral therapy (ART).;<br> Secondary Objective: To conduct a range of analyses to examine:<br> • Virological response to therapy<br> • Changes in CD4+ T cell numbers<br> • Incidence and type of SAEs<br> • Incidence and type of AEs<br> • Changes from baseline in fasted lipid, glucose and selected serum biochemical parameters<br> • Adherence to therapy<br> • Quality of life<br> • Neurocognitive function<br> • Exploratory use of dry blood spot method to measure viral load and EFV concentrations<br> ;Primary end point(s): The primary endpoint is the comparison between treatment groups of proportions of patients with HIV-1 RNA <200 copies/mL 48weeks after randomisation.